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4. Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis

Author

Chertow GM, Block GA, Correa-Rotter R, Drüeke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Trotman ML, Wheeler DC, Parfrey PS., Evolve Team, Chertow G, Parfrey P, Block G, Drüeke T, Goodman W, Herzog C, London G, Mahaffey K, Moe S, Wheeler D, Hennekens C, Baigent C, Brown W, O'Brien P, Anderson S, Hoel J, Szczech L, Patel U, Wampole J, Pun P, Felker M, Inrig J, Shah S, Hernandez A, Patel C, Brennan M, Albizem M, Capper E, Cauchi L, Cheng S, Dehmel B, Dhami K, Durham C, Francioni M, Gadd S, Goodman B, Guimaraes L, Grey N, Hamlin R, Harris C, Harris E, Heavey S, Heiges T, Heiser D, Jaeger P, James M, James P, Karimi S, Kewalramani R, Kraszewski A, Liang J, Maguire J, McCormick K, McFarlane K, Mix C, Modafferi D, Prathikanti R, Ryan C, Santiago N, Schumacher J, Seder C, Shahinfar S, Soares B, Stolman D, Tisher C, Trotman M, Tseng S, Ulias G, Unger P, Vyshenskaya A, Walsh L, White C, Wilde K, Santos J, Zarazaga C, Marin I, Garrote N, Cusumano A, Penalba N, Del Valle E, Juncos L, Saye J, Lef L, Altobelli V, Petraglia G, Rosa-Diez G, Douthat W, Lobo J, Gallart C, Lafalla A, Diez G, Linares B, Lopez N, Ramirez N, Gonzalez R, Valtuille R, Beresan H, Hermida O, Rudolf G, Marchetta N, Rano M, Ramirez M, Garcia N, Gillies A, Jones B, Pedagogos E, Walker R, Talaulikar G, Bannister K, Suranyi M, Kark A, Roger S, Kerr P, Disney A, Mount P, Fraenkel M, Mathew M, Fassett R, Jose M, Hawley C, Lonergan M, Mackie J, Ferrari P, Menahem S, Sabto J, Hutchison B, Langham R, Pollock C, Holzer H, Oberbauer R, Arias I, Graf H, Mayer G, Lhotta K, Neyer U, Klauser-Braun R, Hoerl W, Horn S, Kovarik J, Kramar R, Eigner M, Dhaene M, Billiouw J, De Meester J, Warling X, Cambier-Dwelschauwers P, Evenepoel P, Daelemans R, Dratwa M, Maes B, Stolear J, Dejagere T, Vanwalleghem J, Bouman K, Jadoul M, Peeters J, Vanholder R, Tielemans C, Donck J, Almeida F, de Oliveira J, Burdmann E, Garcia V, Thome F, Deboni L, Bregman R, Lugon J, Araújo S, Ferreira Filho S, Daher Ede F, Baptista M, Carvalho A, d'Avila D, Moyses Neto M, Yu L, Bastos M, Lacativa P, Jorgetti V, Romão Ede A, da Costa JC, Pecoits Filho R, Gordan P, Salgado N, Araújo M, Coelho S, Oliveira I, Moysés R, Vasconcellos L, Batista P, Gross J, Pedrosa A, Cournoyer S, LeBlanc M, Chow S, Karunakaran S, Wong G, Tobe S, Desmeules S, Zimmerman D, Murphy S, Montambault P, Donnelly S, MacRae J, Culleton B, Soroka S, Rabbat C, Jindal K, Vasilevsky M, Michaud M, Wijeyesinghe E, Zacharias J, Lok C, Muirhead N, Verrelli M, Da Roza G, Sapir D, Olgaard K, Daugaard H, Brandi L, Jensen P, Boulechfar H, Ang K, Simon P, Rieu P, Brunet P, Touchard G, Torres P, Combe C, Durrbach A, Ortiz J, Hannedouche T, Vela C, Lionet A, Ryckelynck P, Zaoui P, Choukroun G, Fessi H, Lang P, Stroumza P, Joly D, Mousson C, Laville M, Dellanna F, Erley C, Braun J, Rambausek M, Riegel W, Klingberg M, Schwertfeger E, Wizemann V, Eckardt K, Reichel H, Passauer J, Hübel E, Frischmuth N, Liebl R, Fiedler R, Schwenger V, Voßkühler A, Kunzendorf U, Renders L, Rattensberger D, Rump L, Ketteler M, Neumayer H, Zantvoort F, Stahl R, Ladanyi E, Braun B, Kulcsar I, Mezei I, Csiky B, Rikker C, Arkossy O, Berta K, Szegedi J, Major L, Ferenczi S, Fekete A, Szabo T, Zakar G, Wagner G, Erdelyine S, Borbas B, Eustace J, Reddan D, Capasso G, Locatelli F, Villa G, Cozzolino M, Brancaccio D, Messa P, Bolasco P, Ricciardi B, Malberti F, Moriero E, Cannella G, Ortalda V, Stefoni S, Frascà G, Cappelli G, Albertazzi A, Zoccali C, Farina M, Elli A, Avella F, Ondei P, Mingardi G, Errico R, Losito A, Di Giulio S, Pertosa G, Schena F, Grandaliano G, Gesualdo L, Auricchio M, Bochicchio-Ricardelli T, Correa-Rotter J, Verástegui F, Peña J, Wong A, Cruz-Valdez J, Zamora M, Solis M, Diaz M, Flores M, Sandoval E, van den Dorpel M, Brink H, Van Kuijk W, Vermeij C, Gregoor P, Hagen E, van der Sande F, Klinger M, Nowicki M, Muszytowski M, Bidas K, Bentkowski W, Wiecek A, Ksiazek A, Marczewski K, Ostrowski M, Switalski M, Sulowicz W, Matuszkiewicz-Rowinska J, Mysliwiec M, Durlik M, Rutkowski B, Macario F, Carvalho B, Frazao J, Machado D, Weigert A, Andrusev A, Khrustalev O, Zemtchenkov A, Gurevich K, Staroselsky K, Khadikova N, Rozhinskaya L, Timokhovskaya G, Strokov A, Balkarova O, Ermolenko V, Kolmakova E, Komandenko M, Timofeev M, Shilo V, Shostka G, Smirnov A, Anashkin V, Volgina G, Domashenko O, Gurevich A, Perlin D, García J, Ribes E, Piera E, Lucas M, Galicia M, Prados M, González M, Romero R, de Francisco ÁM, Montenegro J, Santiago C, García F, de La Ossa J, Arrieta J, Pons J, Martín-Malo A, Amigó J, Cases A, Sterner G, Jensen G, Wikström B, Jacobson S, Lund U, Weiss L, Ståhl A, von Albertini B, Burnier M, Meier P, Martin P, Uehlinger D, Dickenmann M, Yaqoob M, Zehnder D, Kalra P, Padmanabhan N, Roe S, Eadington D, Pritchard N, Hutchison A, Davies S, Wilkie M, Davies M, Pai P, Swift P, Kwan J, Goldsmith D, Tomson C, Stratton J, Dasgupta I, Sarkar S, Moustafa M, Gandhi K, Jamal A, Galindo-Ramos E, Tuazon J, Batlle D, Tucker K, Schiller-Moran B, Assefi A, Martinez C, Samuels L, Goldman J, Cangiano-Rivera J, Darwish R, Lee M, Topf J, Kapatkin K, Baer H, Kopelman R, Acharya M, Tharpe D, Bernardo M, Nader P, Guzman-Rivera J, Pergola P, Sekkarie M, Alas E, Zager P, Liss K, Navarro J, Roppolo M, Denu-Ciocca C, Kshirsagar A, El Khatib M, Kant K, Scott D, Murthyr B, Finkelstein F, Keightley G, McCrary R, Pitone J, Cavalieri T, Tsang A, Pellegrino B, Schmidt R, Ahmad S, Brown C, Friedman E, Mittman N, Fadem S, Shapiro W, Reddy M, Goldberger S, Woredekal Y, Agarwal A, Anger M, Haque M, Chidester P, Kohli R, Rubinstein S, Newman G, Gladish R, Ayodeji O, Soman S, Sprague S, Hunt N, Gehr T, Rizk D, Warnock D, Polack D, Pahl M, Fischer D, Dreyer P, James G, Husserl F, Rogers T, Raff A, Sedor J, Silver M, Smith M, Steinberg S, DelGiorno T, Jones E, Cunha P, Cheng J, Pogue V, Blumenthal S, Brown E, Charytan C, Buerkert J, Cook M, Felsenfeld A, Tareen N, Gupta A, Herman T, Diamond S, Hura C, Laski M, MacLaurin J, Plumb T, Brosnahan G, Kumar J, Henriquez M, Poole C, Osanloo E, Matalon A, Sholer C, Arfeen S, Azer M, Belledonne M, Gross M, Dunnigan E, McConnell K, Becker B, Rigolosi R, Spiegel D, Stegman M, Patak R, Streja D, Ranjit U, Youell T, Wooldridge T, Stafford C, Cottiero R, Weinberg M, Schonefeld M, Shahmir E, Hazzan A, Ashfaq A, Bhandari K, Cleveland W, Culpepper M, Golden J, Lai L, Lien Y, Lorica V, Robertson J, Malireddi K, Morse S, Thakur V, Israelit A, Raguram P, Alfred H, Weise W, Al-Saghir F, El Shahawy M, Rastogi A, Nissenson A, Kopyt N, Lynn R, Lea J, McClellan W, Teredesai P, Ong S, Tolkan S, Sugihara J, Minga T, Mehrotra R, Minasian R, Bhatia D, Specter R, Capelli J, Sidhu P, Dalal S, Dykes P, Khan M, Rahim F, Saklayen M, Thomas A, Michael B, Torres M, Al-Bander H, Murray B, Abukurah A, Gupta B, Nosrati S, Raja R, Zeig S, Braun M, Amatya A, Endsley J, Sharon Z, Dolson G, Dumler F, Ntoso K, Rosansky S, Kumar N, Gura V, Thompson N, Goldfarb D, Halligan R, Middleton J, Widerhorn A, Arbeit L, Arruda J, Crouch T, Friedman L, Khokhar S, Mittleman J, Light P, Taparia B, West C, Cotton J, Dhingra R, Kleinman L, Arif F, Lew S, Nammour T, Sterrett J, Williams M, Ramirez J, Rubin J, McCarthy J, Noble S, Chaffin M, Rekhi A., Chertow, Gm, Block, Ga, Correa-Rotter, R, Drüeke, Tb, Floege, J, Goodman, Wg, Herzog, Ca, Kubo, Y, London, Gm, Mahaffey, Kw, Mix, Tc, Moe, Sm, Trotman, Ml, Wheeler, Dc, Parfrey, Ps., Evolve, Team, Chertow, G, Parfrey, P, Block, G, Drüeke, T, Goodman, W, Herzog, C, London, G, Mahaffey, K, Moe, S, Wheeler, D, Hennekens, C, Baigent, C, Brown, W, O'Brien, P, Anderson, S, Hoel, J, Szczech, L, Patel, U, Wampole, J, Pun, P, Felker, M, Inrig, J, Shah, S, Hernandez, A, Patel, C, Brennan, M, Albizem, M, Capper, E, Cauchi, L, Cheng, S, Dehmel, B, Dhami, K, Durham, C, Francioni, M, Gadd, S, Goodman, B, Guimaraes, L, Grey, N, Hamlin, R, Harris, C, Harris, E, Heavey, S, Heiges, T, Heiser, D, Jaeger, P, James, M, James, P, Karimi, S, Kewalramani, R, Kraszewski, A, Liang, J, Maguire, J, Mccormick, K, Mcfarlane, K, Mix, C, Modafferi, D, Prathikanti, R, Ryan, C, Santiago, N, Schumacher, J, Seder, C, Shahinfar, S, Soares, B, Stolman, D, Tisher, C, Trotman, M, Tseng, S, Ulias, G, Unger, P, Vyshenskaya, A, Walsh, L, White, C, Wilde, K, Santos, J, Zarazaga, C, Marin, I, Garrote, N, Cusumano, A, Penalba, N, Del Valle, E, Juncos, L, Saye, J, Lef, L, Altobelli, V, Petraglia, G, Rosa-Diez, G, Douthat, W, Lobo, J, Gallart, C, Lafalla, A, Diez, G, Linares, B, Lopez, N, Ramirez, N, Gonzalez, R, Valtuille, R, Beresan, H, Hermida, O, Rudolf, G, Marchetta, N, Rano, M, Ramirez, M, Garcia, N, Gillies, A, Jones, B, Pedagogos, E, Walker, R, Talaulikar, G, Bannister, K, Suranyi, M, Kark, A, Roger, S, Kerr, P, Disney, A, Mount, P, Fraenkel, M, Mathew, M, Fassett, R, Jose, M, Hawley, C, Lonergan, M, Mackie, J, Ferrari, P, Menahem, S, Sabto, J, Hutchison, B, Langham, R, Pollock, C, Holzer, H, Oberbauer, R, Arias, I, Graf, H, Mayer, G, Lhotta, K, Neyer, U, Klauser-Braun, R, Hoerl, W, Horn, S, Kovarik, J, Kramar, R, Eigner, M, Dhaene, M, Billiouw, J, De Meester, J, Warling, X, Cambier-Dwelschauwers, P, Evenepoel, P, Daelemans, R, Dratwa, M, Maes, B, Stolear, J, Dejagere, T, Vanwalleghem, J, Bouman, K, Jadoul, M, Peeters, J, Vanholder, R, Tielemans, C, Donck, J, Almeida, F, de Oliveira, J, Burdmann, E, Garcia, V, Thome, F, Deboni, L, Bregman, R, Lugon, J, Araújo, S, Ferreira Filho, S, Daher Ede, F, Baptista, M, Carvalho, A, D'Avila, D, Moyses Neto, M, Yu, L, Bastos, M, Lacativa, P, Jorgetti, V, Romão Ede, A, da Costa, Jc, Pecoits Filho, R, Gordan, P, Salgado, N, Araújo, M, Coelho, S, Oliveira, I, Moysés, R, Vasconcellos, L, Batista, P, Gross, J, Pedrosa, A, Cournoyer, S, Leblanc, M, Chow, S, Karunakaran, S, Wong, G, Tobe, S, Desmeules, S, Zimmerman, D, Murphy, S, Montambault, P, Donnelly, S, Macrae, J, Culleton, B, Soroka, S, Rabbat, C, Jindal, K, Vasilevsky, M, Michaud, M, Wijeyesinghe, E, Zacharias, J, Lok, C, Muirhead, N, Verrelli, M, Da Roza, G, Sapir, D, Olgaard, K, Daugaard, H, Brandi, L, Jensen, P, Boulechfar, H, Ang, K, Simon, P, Rieu, P, Brunet, P, Touchard, G, Torres, P, Combe, C, Durrbach, A, Ortiz, J, Hannedouche, T, Vela, C, Lionet, A, Ryckelynck, P, Zaoui, P, Choukroun, G, Fessi, H, Lang, P, Stroumza, P, Joly, D, Mousson, C, Laville, M, Dellanna, F, Erley, C, Braun, J, Rambausek, M, Riegel, W, Klingberg, M, Schwertfeger, E, Wizemann, V, Eckardt, K, Reichel, H, Passauer, J, Hübel, E, Frischmuth, N, Liebl, R, Fiedler, R, Schwenger, V, Voßkühler, A, Kunzendorf, U, Renders, L, Rattensberger, D, Rump, L, Ketteler, M, Neumayer, H, Zantvoort, F, Stahl, R, Ladanyi, E, Braun, B, Kulcsar, I, Mezei, I, Csiky, B, Rikker, C, Arkossy, O, Berta, K, Szegedi, J, Major, L, Ferenczi, S, Fekete, A, Szabo, T, Zakar, G, Wagner, G, Erdelyine, S, Borbas, B, Eustace, J, Reddan, D, Capasso, G, Locatelli, F, Villa, G, Cozzolino, M, Brancaccio, D, Messa, P, Bolasco, P, Ricciardi, B, Malberti, F, Moriero, E, Cannella, G, Ortalda, V, Stefoni, S, Frascà, G, Cappelli, G, Albertazzi, A, Zoccali, C, Farina, M, Elli, A, Avella, F, Ondei, P, Mingardi, G, Errico, R, Losito, A, Di Giulio, S, Pertosa, G, Schena, F, Grandaliano, G, Gesualdo, L, Auricchio, M, Bochicchio-Ricardelli, T, Correa-Rotter, J, Verástegui, F, Peña, J, Wong, A, Cruz-Valdez, J, Zamora, M, Solis, M, Diaz, M, Flores, M, Sandoval, E, van den Dorpel, M, Brink, H, Van Kuijk, W, Vermeij, C, Gregoor, P, Hagen, E, van der Sande, F, Klinger, M, Nowicki, M, Muszytowski, M, Bidas, K, Bentkowski, W, Wiecek, A, Ksiazek, A, Marczewski, K, Ostrowski, M, Switalski, M, Sulowicz, W, Matuszkiewicz-Rowinska, J, Mysliwiec, M, Durlik, M, Rutkowski, B, Macario, F, Carvalho, B, Frazao, J, Machado, D, Weigert, A, Andrusev, A, Khrustalev, O, Zemtchenkov, A, Gurevich, K, Staroselsky, K, Khadikova, N, Rozhinskaya, L, Timokhovskaya, G, Strokov, A, Balkarova, O, Ermolenko, V, Kolmakova, E, Komandenko, M, Timofeev, M, Shilo, V, Shostka, G, Smirnov, A, Anashkin, V, Volgina, G, Domashenko, O, Gurevich, A, Perlin, D, García, J, Ribes, E, Piera, E, Lucas, M, Galicia, M, Prados, M, González, M, Romero, R, de Francisco, Ám, Montenegro, J, Santiago, C, García, F, de La Ossa, J, Arrieta, J, Pons, J, Martín-Malo, A, Amigó, J, Cases, A, Sterner, G, Jensen, G, Wikström, B, Jacobson, S, Lund, U, Weiss, L, Ståhl, A, von Albertini, B, Burnier, M, Meier, P, Martin, P, Uehlinger, D, Dickenmann, M, Yaqoob, M, Zehnder, D, Kalra, P, Padmanabhan, N, Roe, S, Eadington, D, Pritchard, N, Hutchison, A, Davies, S, Wilkie, M, Davies, M, Pai, P, Swift, P, Kwan, J, Goldsmith, D, Tomson, C, Stratton, J, Dasgupta, I, Sarkar, S, Moustafa, M, Gandhi, K, Jamal, A, Galindo-Ramos, E, Tuazon, J, Batlle, D, Tucker, K, Schiller-Moran, B, Assefi, A, Martinez, C, Samuels, L, Goldman, J, Cangiano-Rivera, J, Darwish, R, Lee, M, Topf, J, Kapatkin, K, Baer, H, Kopelman, R, Acharya, M, Tharpe, D, Bernardo, M, Nader, P, Guzman-Rivera, J, Pergola, P, Sekkarie, M, Alas, E, Zager, P, Liss, K, Navarro, J, Roppolo, M, Denu-Ciocca, C, Kshirsagar, A, El Khatib, M, Kant, K, Scott, D, Murthyr, B, Finkelstein, F, Keightley, G, Mccrary, R, Pitone, J, Cavalieri, T, Tsang, A, Pellegrino, B, Schmidt, R, Ahmad, S, Brown, C, Friedman, E, Mittman, N, Fadem, S, Shapiro, W, Reddy, M, Goldberger, S, Woredekal, Y, Agarwal, A, Anger, M, Haque, M, Chidester, P, Kohli, R, Rubinstein, S, Newman, G, Gladish, R, Ayodeji, O, Soman, S, Sprague, S, Hunt, N, Gehr, T, Rizk, D, Warnock, D, Polack, D, Pahl, M, Fischer, D, Dreyer, P, James, G, Husserl, F, Rogers, T, Raff, A, Sedor, J, Silver, M, Smith, M, Steinberg, S, Delgiorno, T, Jones, E, Cunha, P, Cheng, J, Pogue, V, Blumenthal, S, Brown, E, Charytan, C, Buerkert, J, Cook, M, Felsenfeld, A, Tareen, N, Gupta, A, Herman, T, Diamond, S, Hura, C, Laski, M, Maclaurin, J, Plumb, T, Brosnahan, G, Kumar, J, Henriquez, M, Poole, C, Osanloo, E, Matalon, A, Sholer, C, Arfeen, S, Azer, M, Belledonne, M, Gross, M, Dunnigan, E, Mcconnell, K, Becker, B, Rigolosi, R, Spiegel, D, Stegman, M, Patak, R, Streja, D, Ranjit, U, Youell, T, Wooldridge, T, Stafford, C, Cottiero, R, Weinberg, M, Schonefeld, M, Shahmir, E, Hazzan, A, Ashfaq, A, Bhandari, K, Cleveland, W, Culpepper, M, Golden, J, Lai, L, Lien, Y, Lorica, V, Robertson, J, Malireddi, K, Morse, S, Thakur, V, Israelit, A, Raguram, P, Alfred, H, Weise, W, Al-Saghir, F, El Shahawy, M, Rastogi, A, Nissenson, A, Kopyt, N, Lynn, R, Lea, J, Mcclellan, W, Teredesai, P, Ong, S, Tolkan, S, Sugihara, J, Minga, T, Mehrotra, R, Minasian, R, Bhatia, D, Specter, R, Capelli, J, Sidhu, P, Dalal, S, Dykes, P, Khan, M, Rahim, F, Saklayen, M, Thomas, A, Michael, B, Torres, M, Al-Bander, H, Murray, B, Abukurah, A, Gupta, B, Nosrati, S, Raja, R, Zeig, S, Braun, M, Amatya, A, Endsley, J, Sharon, Z, Dolson, G, Dumler, F, Ntoso, K, Rosansky, S, Kumar, N, Gura, V, Thompson, N, Goldfarb, D, Halligan, R, Middleton, J, Widerhorn, A, Arbeit, L, Arruda, J, Crouch, T, Friedman, L, Khokhar, S, Mittleman, J, Light, P, Taparia, B, West, C, Cotton, J, Dhingra, R, Kleinman, L, Arif, F, Lew, S, Nammour, T, Sterrett, J, Williams, M, Ramirez, J, Rubin, J, Mccarthy, J, Noble, S, Chaffin, M, and Rekhi, A.

Subjects
Adult, Male, Dialysis, Cinacalcet, Cardiovascular Disease, medicine.medical_specialty, Calcimimetic, medicine.medical_treatment, Naphthalenes, Coronary artery disease, Renal Dialysis, Internal medicine, Odds Ratio, medicine, Humans, Intensive care medicine, Aged, Etelcalcetide, Hyperparathyroidism, Hypocalcemia, business.industry, General Medicine, Middle Aged, medicine.disease, Intention to Treat Analysis, Cardiovascular Diseases, Parathyroid Hormone, Cinacalcet Hydrochloride, Kidney Failure, Chronic, Female, Hyperparathyroidism, Secondary, Secondary hyperparathyroidism, business, medicine.drug
Abstract

Disorders of mineral metabolism, including secondary hyperparathyroidism, are thought to contribute to extraskeletal (including vascular) calcification among patients with chronic kidney disease. It has been hypothesized that treatment with the calcimimetic agent cinacalcet might reduce the risk of death or nonfatal cardiovascular events in such patients.In this clinical trial, we randomly assigned 3883 patients with moderate-to-severe secondary hyperparathyroidism (median level of intact parathyroid hormone, 693 pg per milliliter [10th to 90th percentile, 363 to 1694]) who were undergoing hemodialysis to receive either cinacalcet or placebo. All patients were eligible to receive conventional therapy, including phosphate binders, vitamin D sterols, or both. The patients were followed for up to 64 months. The primary composite end point was the time until death, myocardial infarction, hospitalization for unstable angina, heart failure, or a peripheral vascular event. The primary analysis was performed on the basis of the intention-to-treat principle.The median duration of study-drug exposure was 21.2 months in the cinacalcet group, versus 17.5 months in the placebo group. The primary composite end point was reached in 938 of 1948 patients (48.2%) in the cinacalcet group and 952 of 1935 patients (49.2%) in the placebo group (relative hazard in the cinacalcet group vs. the placebo group, 0.93; 95% confidence interval, 0.85 to 1.02; P=0.11). Hypocalcemia and gastrointestinal adverse events were significantly more frequent in patients receiving cinacalcet.In an unadjusted intention-to-treat analysis, cinacalcet did not significantly reduce the risk of death or major cardiovascular events in patients with moderate-to-severe secondary hyperparathyroidism who were undergoing dialysis. (Funded by Amgen; EVOLVE ClinicalTrials.gov number, NCT00345839.).

Published
2012
Full Text
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5. Cinacalcet, fibroblast growth factor-23, and cardiovascular disease in hemodialysis: The evaluation of cinacalcet HCl therapy to lower cardiovascular events (EVOLVE) trial

Author

Moe S. M., Chertow G. M., Parfrey P. S., Kubo Y., Block G. A., Correa-Rotter R., Drueke T. B., Herzog C. A., London G. M., Mahaffey K. W., Wheeler D. C., Stolina M., Dehmel B., Goodman W. G., Floege J., Santos J., Najun Zarazaga C., Marin I., Garrote N., Cusumano A., Penalba N., Del Valle E., Juncos L., Martinez Saye J., Lef L., Altobelli V., Petraglia G., Rosa Diez G., Douthat W., Lobo J., Gallart C., Lafalla A., Diez G., Linares B., Lopez N., Ramirez N., Gonzalez R., Valtuille R., Beresan H., Hermida O., Rudolf G., Marchetta N., Rano M., Ramirez M., Garcia N., Gillies A., Jones B., Pedagogos E., Walker R., Talaulikar G., Bannister K., Suranyi M., Kark A., Roger S., Kerr P., Disney A., Mount P., Fraenkel M., Mathew M., Fassett R., Jose M., Hawley C., Lonergan M., Mackie J., Ferrari P., Menahem S., Sabto J., Hutchison B., Langham R., Pollock C., Holzer H., Oberbauer R., Arias I., Graf H., Mayer G., Lhotta K., Neyer U., Klauser R., Hoerl W., Horn S., Kovarik J., Kramar R., Eigner M., Dhaene M., Billiouw J., De Meester J., Warling X., Cambier-Dwelschauwers P., Evenepoel P., Daelemans R., Dratwa M., Maes B., Stolear J., Dejagere T., Vanwalleghem J., Bouman K., Jadoul M., Peeters J., Vanholder R., Tielemans C., Donck J., Almeida F., Picollo De Oliveira J., Burdmann E., Garcia V., Saldanha Thome F., Deboni L., Bregman R., Lugon J., Araujo S., Ferreira Filho S., De Francesco Daher E., Sperto Baptista M., Carvalho A., D'Avila D., Moyses Neto M., Yu L., Bastos M., Sampaio Lacativa P., Jorgetti V., De Almeida Romao E., Cardeal Da Costa J., Pecoits Filho R., Gordan P., Salgado N., Teixeira Araujo M., Neiva Coelho S., Oliveira I., Moyses R., Vasconcellos L., Batista P., Luiz Gross J., Pedrosa A., Cournoyer S., LeBlanc M., Chow S., Karunakaran S., Wong G., Tobe S., Desmeules S., Zimmerman D., Murphy S., Montambault P., Donnelly S., MacRae J., Culleton B., Soroka S., Rabbat C., Jindal K., Vasilevsky M., Michaud M., Wijeyesinghe E., Zacharias J., Lok C., Muirhead N., Verrelli M., Da Roza G., Sapir D., Olgaard K., Daugaard H., Brandi L., Jensen P., Boulechfar H., Ang K., Simon P., Rieu P., Brunet P., Touchard G., Urena Torres P., Combe C., Durrbach A., Ortiz J., 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Strokov, A., Balkarova, O., Ermolenko, V., Kolmakova, E., Komandenko, M., Timofeev, M., Shilo, V., Shostka, G., Smirnov, A., Anashkin, V., Volgina, G., Domashenko, O., Gurevich, A., Perlin, D., Martinez Garcia, J., Andres Ribes, E., Coll Piera, E., Fernandez Lucas, M., Galicia, M., Prados, M., Gonzalez, M., Romero, R., Martin de Francisco, A., Montenegro, J., Santiago, C., Garcia, F., Alcazar De La Ossa, J., Arrieta, J., Pons, J., Martin-Malo, A., Soler Amigo, J., Cases, A., Sterner, G., Jensen, G., Wikstrom, B., Jacobson, S., Lund, U., Weiss, L., Stahl, A., Von Albertini, B., Burnier, M., Meier, P., Martin, P., Uehlinger, D., Dickenmann, M., Yaqoob, M., Zehnder, D., Kalra, P., Padmanabhan, N., Roe, S., Eadington, D., Pritchard, N., Hutchison, A., Davies, S., Wilkie, M., Davies, M., Pai, P., Swift, P., Kwan, J., Goldsmith, D., Tomson, C., Stratton, J., Dasgupta, I., Sarkar, S., Moustafa, M., Gandhi, K., Jamal, A., Galindo-Ramos, E., Tuazon, J., Batlle, D., Tucker, K., Schiller-Moran, 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D., Cheng, J., Pogue, V., Blumenthal, S., Brown, E., Charytan, C., Buerkert, J., Cook, M., Felsenfeld, A., Tareen, N., Gupta, A., Herman, T., Diamond, S., Hura, C., Laski, M., Maclaurin, J., Plumb, T., Brosnahan, G., Kumar, J., Henriquez, M., Poole, C., Osanloo, E., Matalon, A., Sholer, C., Arfeen, S., Azer, M., Belledonne, M., Gross, M., Dunnigan, E., Mcconnell, K., Becker, B., Skinner, F., Rigolosi, R., Spiegel, D., Stegman, M., Patak, R., Streja, D., Ranjit, U., Youell, T., Wooldridge, T., Stafford, C., Cottiero, R., Weinberg, M., Schonefeld, M., Shahmir, E., Hazzan, A., Ashfaq, A., Bhandari, K., Cleveland, W., Culpepper, M., Golden, J., Lai, L., Lien, Y., Lorica, V., Robertson, J., Malireddi, K., Morse, S., Thakur, V., Israelit, A., Raguram, P., Alfred, H., Weise, W., Al-Saghir, F., El Shahawy, M., Rastogi, A., Nissenson, A., Kopyt, N., Lynn, R., Lea, J., Mcclellan, W., Teredesai, P., Ong, S., Tolkan, S., Sugihara, J., Minga, T., Mehrotra, R., Minasian, R., Bhatia, D., Specter, R., Capelli, J., Sidhu, P., Dalal, S., Dykes, P., Khan, M., Rahim, F., Saklayen, M., Thomas, A., Michael, B., Torres, M., Al-Bander, H., Murray, B., Abukurah, A., Gupta, B., Nosrati, S., Raja, R., Zeig, S., Braun, M., Amatya, A., Endsley, J., Sharon, Z., Dolson, G., Dumler, F., Ntoso, K., Rosansky, S., Kumar, N., Gura, V., Thompson, N., Goldfarb, D., Halligan, R., Middleton, J., Widerhorn, A., Arbeit, L., Arruda, J., Crouch, T., Friedman, L., Khokhar, S., Mittleman, J., Light, P., Taparia, B., West, C., Cotton, J., Dhingra, R., Kleinman, L., Arif, F., Lew, S., Nammour, T., Sterrett, J., Williams, M., Ramirez, J., Rubin, J., Mccarthy, J., Noble, S., Chaffin, M., Rekhi, A., and Clinical sciences

Subjects
Adult, Male, Fibroblast growth factor 23, medicine.medical_specialty, Cinacalcet, Calcimimetic, medicine.medical_treatment, Naphthalenes, Hyperthyroidism, Gastroenterology, ventricular remodeling, Renal Dialysis, Cinacalcet Hydrochloride, Physiology (medical), Internal medicine, medicine, Humans, renal insufficiency, chronic, Aged, Etelcalcetide, calcium, business.industry, Research Support, Non-U.S. Gov't, death, sudden, cardiac, Middle Aged, arrhythmias, cardiac, Cardiovascular Diseases, Female, Fibroblast Growth Factors, Cardiology and Cardiovascular Medicine, medicine.disease, Fibroblast Growth Factor-23, Endocrinology, Randomized Controlled Trial, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug, Kidney disease
Abstract

Background— Patients with kidney disease have disordered bone and mineral metabolism, including elevated serum concentrations of fibroblast growth factor-23 (FGF23). These elevated concentrations are associated with cardiovascular and all-cause mortality. The objective was to determine the effects of the calcimimetic cinacalcet (versus placebo) on reducing serum FGF23 and whether changes in FGF23 are associated with death and cardiovascular events. Methods and Results— This was a secondary analysis of a randomized clinical trial comparing cinacalcet to placebo in addition to conventional therapy (phosphate binders/vitamin D) in patients receiving hemodialysis with secondary hyperparathyroidism (intact parathyroid hormone ≥300 pg/mL). The primary study end point was time to death or a first nonfatal cardiovascular event (myocardial infarction, hospitalization for angina, heart failure, or a peripheral vascular event). This analysis included 2985 patients (77% of randomized) with serum samples at baseline and 2602 patients (67%) with samples at both baseline and week 20. The results demonstrated that a significantly larger proportion of patients randomized to cinacalcet had ≥30% (68% versus 28%) reductions in FGF23. Among patients randomized to cinacalcet, a ≥30% reduction in FGF23 between baseline and week 20 was associated with a nominally significant reduction in the primary composite end point (relative hazard, 0.82; 95% confidence interval, 0.69–0.98), cardiovascular mortality (relative hazard, 0.66; 95% confidence interval, 0.50–0.87), sudden cardiac death (relative hazard, 0.57; 95% confidence interval, 0.37–0.86), and heart failure (relative hazard, 0.69; 95% confidence interval, 0.48–0.99). Conclusions— Treatment with cinacalcet significantly lowers serum FGF23. Treatment-induced reductions in serum FGF23 are associated with lower rates of cardiovascular death and major cardiovascular events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00345839.

Published
2015

6. Prévention des complications thrombotiques de cathéters tunnélisés en dialyse par l’utilisation prophylactique d’une solution verrou contenant de l’urokinase : une étude prospective randomisée contrôlée en double-aveugle

Author

Bonkain, F., primary, Stolear, J.C., additional, Catalano, C., additional, Vandervelde, D., additional, Treille, S., additional, Couttenye, M.M., additional, Dhondt, A., additional, Libertalis, M., additional, Tielemans, C., additional, and Wissing, K.M., additional

Published
2018
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10. Effect of membrane permeability on survival of hemodialysis patients

Author

Locatelli F, Martin Malo A, Hannedouche T, Loureiro A, Papadimitriou M, Wizemann V, Jacobson SH, Czekalski S, Ronco C, Vanholder R, La Milia V, Pozzi M, Di Filippo S, La Greca G, Brendolan A, Crepaldi C, Maschio G, Loschiavo C, Barbieri C, Milanesi F, Redaelli B, Stella A, Viganò MR, Stellato T, Villa G, Segagli S, Montagna G, Quarello F, Vallero A, Forneris G, Borghi M, Tagliaferri M, Palmerio G, Imbasciati E, Farina M, Bucci R, Stallone C, Aucella F, Bellazzi C, De Vincenti A, Giannattasio M, Detomaso F, Malberti F, Pecchini P, Fabris A, Zanella M, Feriani M, Genchi R, Fraticelli M, D'Amico M, Bernardi LE, Palumbo R, De Cicco C, Pietrzak I, Drobnik M, Weyde W, Krajewska M, Penar J, Aljama P, Martín Malo A, Berdud I, Alvarez de Lara MA, Navas A, Martín García J, Chacón JC, Junco E, López Gómez JM, Villaverde M, Bustamante J, Martín García D, Sánchez L, Montenegro J, Ocharan J, Barril G, Besada E, Pastor JM, Gallar P, Almaraz M, Alcalá M, Silgado G, Gruss E, Portolés JM, Delgado R, Bittar H, Nony A, Chanard J, Randoux C, Maheut H, Dimitrov Y, Bouiller M, Simon P, Kim SA, Cremault A, Ryckelynck JP, Levaltier B, Jonon B, Saidani F, Maurice F, Kessler M, Hachicha M, Reach I, Bataille P, Nour D, Paiva A, Cruz J, Carvalho D, Buinho F, Santos JP, Sotto K, Sousa S, da Cruz L, Henriques C, Santos J, Vinhas J, Assunçao J, Memmos D, Belechri AM, Giamalis P, Dhondt A, Veys N, Van Biesen W, Verbeelen D, Krzesinski JM, Tielemans C, Lins R, Larsson K, Kurkus J, Weiss L, Welander G, Seidel S, Lotz C, Gruber H, Weinreich T, Rawer P, Bommer J, Hoenich NA, Leunissen K.L., STEFONI, SERGIO, CIANCIOLO, GIUSEPPE, BARALDI, OLGA, Locatelli F, Martin-Malo A, Hannedouche T, Loureiro A, Papadimitriou M, Wizemann V, Jacobson SH, Czekalski S, Ronco C, Vanholder R, La Milia V, Pozzi M, Di Filippo S, La Greca G, Brendolan A, Crepaldi C, Stefoni S, Cianciolo G, Baraldi O, Maschio G, Loschiavo C, Barbieri C, Milanesi F, Redaelli B, Stella A, Viganò MR, Stellato T, Villa G, Segagli S, Montagna G, Quarello F, Vallero A, Forneris G, Borghi M, Tagliaferri M, Palmerio G, Imbasciati E, Farina M, Bucci R, Stallone C, Aucella F, Bellazzi C, De Vincenti A, Giannattasio M, Detomaso F, Malberti F, Pecchini P, Fabris A, Zanella M, Feriani M, Genchi R, Fraticelli M, D'Amico M, Bernardi LE, Palumbo R, De Cicco C, Pietrzak I, Drobnik M, Weyde W, Krajewska M, Penar J, Aljama P, Martín Malo A, Berdud I, Alvarez de Lara MA, Navas A, Martín García J, Chacón JC, Junco E, López Gómez JM, Villaverde M, Bustamante J, Martín García D, Sánchez L, Montenegro J, Ocharan J, Barril G, Besada E, Pastor JM, Gallar P, Almaraz M, Alcalá M, Silgado G, Gruss E, Portolés JM, Delgado R, Bittar H, Nony A, Chanard J, Randoux C, Maheut H, Dimitrov Y, Bouiller M, Simon P, Kim SA, Cremault A, Ryckelynck JP, Levaltier B, Jonon B, Saidani F, Maurice F, Kessler M, Hachicha M, Reach I, Bataille P, Nour D, Paiva A, Cruz J, Carvalho D, Buinho F, Santos JP, Sotto K, Sousa S, da Cruz L, Henriques C, Santos J, Vinhas J, Assunçao J, Memmos D, Belechri AM, Giamalis P, Dhondt A, Veys N, Van Biesen W, Verbeelen D, Krzesinski JM, Tielemans C, Lins R, Larsson K, Kurkus J, Weiss L, Welander G, Seidel S, Lotz C, Gruber H, Weinreich T, Rawer P, Bommer J, Hoenich NA, and Leunissen KL.

Subjects
medicine.medical_specialty, HEMODIALYSIS, HEMODIALYSIS PATIENT SURVIVAL, Membrane permeability, business.industry, medicine.medical_treatment, HIGH-FLUX HEMODIALYSIS MEMBRANES, Hazard ratio, LOW-FLUX HEMODIALYSIS MEMBRANES, General Medicine, ALBUMIN, Gastroenterology, Confidence interval, law.invention, Randomized controlled trial, Nephrology, law, Internal medicine, Clinical endpoint, Medicine, Hemodialysis, business, Survival rate, Dialysis
Abstract

The effect of high-flux hemodialysis membranes on patient survival has not been unequivocally determined. In this prospective, randomized clinical trial, we enrolled 738 incident hemodialysis patients, stratified them by serum albumin < or = 4 and >4 g/dl, and assigned them to either low-flux or high-flux membranes. We followed patients for 3 to 7.5 yr. Kaplan-Meier survival analysis showed no significant difference between high-flux and low-flux membranes, and a Cox proportional hazards model concurred. Patients with serum albumin < or = 4 g/dl had significantly higher survival rates in the high-flux group compared with the low-flux group (P = 0.032). In addition, a secondary analysis revealed that high-flux membranes may significantly improve survival of patients with diabetes. Among those with serum albumin < or = 4 g/dl, slightly different effects among patients with and without diabetes suggested a potential interaction between diabetes status and low serum albumin in the reduction of risk conferred by high-flux membranes. In summary, we did not detect a significant survival benefit with either high-flux or low-flux membranes in the population overall, but the use of high-flux membranes conferred a significant survival benefit among patients with serum albumin < or = 4 g/dl. The apparent survival benefit among patients who have diabetes and are treated with high-flux membranes requires confirmation given the post hoc nature of our analysis.

Published
2009

11. Geographical variability of patient characteristics and treatment patterns affect outcomes for incident hemodialysis patients

Author

Martin-Malo, A., Papadimitriou, M., Cruz, J., Bustamante, J., Verbeelen, D., Nony, A., Vanholder, R., Jacobson, S. H., Montenegro, J., Hannedouche, T., Wizemann, V., Locatelli, F., La Milia, V., Pozzi, M., Di Filippo, S., La Greca, G., Ronco, C., Brendolan, A., Crepaldi, C., Stefoni, S., Ciancialo, G., Baraldi, O., Maschio, G., Loschiavo, C., Barbieri, C., Milanesi, F., Redaelli, B., Stella, A., Vigano, M. R., Stellato, T., Villa, G., Segagli, S., Montagna, G., Quarello, F., Vallero, A., Forneris, G., Borghi, M., Tagliaferri, M., Palmerio, G., Imbasciati, E., Farina, M., Bucci, R., Stallone, C., Aucella, F., Bellazzi, C., De Vincenti, A., Giannattasio, M., Detomaso, F., Malberti, F., Pecchini, P., Fabris, A., Zanella, M., Feriani, M., Genchi, R., Fraticelli, M., D'Amico, M., Bernardi, L. E., Palumbo, R., De Cicco, C., Czekalski, S., Pietrzak, I., Drobnik, M., Weyde, W., Krajewska, M., Penar, J., Aljama, P., Martin Malo, A., Berdud, I., Alvarez De Lara, M. A., Navas, A., Martin Garcia, J., Chacon, J. C., Junco, E., Lopez Gomez, J. M., Villaverde, M., Martin Garcia, D., Sanchez, L., Ocharan, J., Barril, G., Besada, E., Pastor, J. M., Gallar, P., Almaraz, M., Alcala, M., Silgado, G., Gruss, E., Portoles, J. M., Delgado, R., Bittar, H., Chanard, J., Randoux, C., Maheut, H., Dimitrov, Y., Bouiller, M., Simon, P., Ang, K. S., Cremault, A., Ryckelynck, J. -P., Levaltier, B., Jonon, B., Saidani, F., Maurice, F., Kessler, M., Hachicha, M., Reach, I., Bataille, P., Nour, D., Loureiro, A., Paiva, A., Carvalho, D., Buinho, F., Santos, J. P., Sotto, K., Sousa, S., Da Cruz, L., Henriques, C., Santos, J., Vinhas, J., Assuncao, J., Memmos, D., Belechri, A. M., Giamalis, P., Dhondt, A., Veys, N., Van Biesen, W., Krzesinski, J. -M., Tielemans, C., Lins, R., Larsson, K., Kurkus, J., Weiss, L., Welander, G., Seidel, S., Lotz, C., Gruber, H., Weinreich, T., Rawer, P., Martin-Malo, Alejandro, Papadimitriou, Menelao, Cruz, Joao, Bustamante, Jesu, Verbeelen, Dierik, Nony, Alain, Vanholder, Raymond, Jacobson, Stefan H., Montenegro, Jesu, Hannedouche, Thierry, Wizemann, Volker, Locatelli, Francesco, Membrane Permeability Outcome (MPO) Study Group [.., Baraldi, Olga, and ].

Subjects
Male, Pediatrics, Epidemiology, Prevalence, Comorbidity, Kaplan-Meier Estimate, Comorbidities, Renal Dialysi, Cardiovascular Disease, Medicine, education.field_of_study, Europe, Hemodialysis, Mortality, Practice patterns, Hazard ratio, Diabetes Mellitu, Vascular Access Device, Middle Aged, Treatment Outcome, Cardiovascular Diseases, Nephrology, Female, Comorbiditie, Hemodialysi, Vascular Access Devices, Human, medicine.medical_specialty, Membrane permeability, Population, Permeability, Practice pattern, Renal Dialysis, Confidence Intervals, Diabetes Mellitus, Humans, Renal Insufficiency, Chronic, education, Survival analysis, Serum Albumin, Proportional Hazards Models, Aged, Analysis of Variance, business.industry, Proportional hazards model, Membranes, Artificial, Cholesterol, LDL, medicine.disease, Proportional Hazards Model, Calcium, business, Confidence Interval, Demography, Kidney disease
Abstract

Background: Geographical differences in disease prevalence and mortality have been described in the general population and in chronic kidney disease patients in Europe. In this secondary analysis of the Membrane Permeability Outcome (MPO) study, we addressed differences in patient and treatment patterns, and whether these affect patient outcomes. Methods: Participating countries were grouped according to geographical location; thus study centers in France, Greece, Italy, Portugal and Spain were allocated to southern Europe (n=499), and those in all other countries (Belgium, Germany, Poland and Sweden) to northern Europe (n=148). Descriptive analysis of patient and treatment patterns at study start, as well as survival analysis, was performed. Results: In patients from the northern European countries, a higher prevalence of diabetes mellitus and of cardiovascular disease was observed than in those from southern Europe (diabetes 35.1% vs. 21.0%, p=0.0007; cardiovascular disease 40.5% vs. 22.8%, p

Published
2013

12. Effet de la dialyse isonatrique par hémodiafiltration avec régénération de l’ultrafiltrat sur le contrôle tensionnel : essai randomisé contrôlé

Author

Chevalier, L., primary, Tielemans, C., additional, Debelle, F., additional, Vandervelde, D., additional, Fumeron, C., additional, Mandart, L., additional, Stolear, J.C., additional, Simon, I., additional, Delmas, Y., additional, Testa, A., additional, Tezenas, S., additional, and Mercadal, L., additional

Published
2015
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13. [Experimental nephrology unit: overview and research projects]

Author

Deschodt-Lanckman M, Mh, Antoine, Frédéric Debelle, Pozdzik A, Gastaldello K, Simon I, Husson C, De Prez E, Tielemans C, and Nortier J

Subjects
Belgium, Nephrology, Research Design, International Cooperation, Models, Animal, Animals
Abstract

After a short historical background of the Laboratory, the main research topics--renal toxicology, physiopathology of renal interstitial fibrosis and hormonology--are described in the perspective of a partnership between research clinicians and full time scientists. National as well as international scientific collaborations underline the need of combining expertises, stimulating also the training of youngest colleagues to the experimental approach of their future discipline.

Published
2008

14. Current management of secondary hyperparathyroidism: a multicenter observational study (COSMOS)

Author

Cannata-Andía, J. B., Fernández-Martín, J. L., Zoccali, C., London, G. M., Locastelli, F., Ketteler, M., Ferreira, A., Covic, A., Floege, J., Górriz, J. L., Rutkowski, B., Memmos, D. E., Verbeelen, D., Tielemans, C., Teplan, V., Bos, W. J., Judit Nagy, Kramar, R., Goldsmith, D. J. A., Martin, P. -Y, Wüthrich, R. P., Pavlovic, D., Benedik, M., University of Zurich, and Cannata-Andía, J B

Subjects
ddc:616, Research Design, 2727 Nephrology, Kidney Diseases/complications, 610 Medicine & health, Observation, Hyperparathyroidism, Secondary/*diagnosis/etiology/metabolism, Renal Dialysis/adverse effects, Bone Density, Renal Dialysis, Humans, Multicenter Studies as Topic, 10035 Clinic for Nephrology, Hyperparathyroidism, Secondary, Kidney Diseases, Biological Markers/analysis, Biomarkers, Multicenter Studies as Topic/methods
Abstract

STUDY AIMS: To survey bone mineral disturbances in the hemodialysis (HD) population in Europe and current clinical practice in Europe for the prevention, diagnosis and treatment of secondary hyperparathyroidism (SHPT) in HD patients. PRIMARY OBJECTIVES: First, to estimate the prevalence of Kidney Disease Outcomes Quality Initiative (K/DOQI) guideline achievement in a representative sample of European hemodialysis subjects. As part of this objective, we will investigate the prevalence of achievement by type of dialysis, type of center and time on dialysis (less than or greater than 1 year). Among new dialysis subjects (less than 1 year), we will evaluate prevalence of K/DOQI target achievement until the end of the study. The study will run for 3 years. Second, to estimate the association of bone mineral markers (parathyroid hormone [PTH], calcium [Ca], serum phosphorus [P] and calcium phosphate product [CaxP]) classified by achievement of K/DOQI targets with mortality and overall cardiovascular hospitalization. Third, to characterize the longitudinal changes in bone mineral markers. As part of this objective, we will describe the patterns and predictors of bone mineral markers and achievement, with K/DOQI targets, using repeated measurements on individuals over time. SECONDARY OBJECTIVES: First, To estimate the association of bone mineral markers (PTH, Ca, P and CaxP) classified by achievement of K/DOQI targets with specific cardiovascular outcomes, parathyroidectomy, manifest bone disease (including incidence of symptomatic bone fractures), hospitalizations and vascular access. Second, to evaluate the additional value of albumin and hemoglobin levels in conjunction with bone mineral markers in the prediction of mortality and clinical events.

Published
2008
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16. Le département médico-chirurgical de Néphrologie Dialyse et Transplantation Rénale

Author

Vanherweghem, J L, Abramowicz, D, Broeders, N, De Pauw, L, Le Moine, A, Nortier, J, Tielemans, C, Wissing, M, Faculteit van de Geneeskunde en Farmacie, Faculteit Economische en Sociale Wetenschappen en Solvay Business School, and Observerende Klinische wetenschappen

Subjects
Hospitals, University, Biomedical Research, Hemodialysis Units, Hospital, Belgium, Journal Article, Humans, kidney transplantation, Kidney Diseases, English Abstract, Review, Surgery Department, Hospital
Abstract

The Department of Nephrology of the Hospital Erasme, opened 25 years ago, is now performing, each year, 22,000 hemodialysis sessions, 800 patient-weeks of peritoneal dialysis treatment and 70 renal grafts. Scientific contributions of the department deal with vascular access for hemodialysis, susceptibility to infections of dialyzed patients, parathyroid surgery, biocompatibility of dialysis membranes, predictive factors of renal graft survival, immunosuppression with monoclonal antibodies, experimental studies of graft tolerance and rejection, toxic nephropathies. The most original contributions are related to anaphylactoïd reactions in hemodialysis by association of acrylonitrile membranes with inhibition of the converting enzyme, to advantages and side effects of OKT3 monoclonal antibody and to discovery and study of the Chinese herbs nephropathy.

Published
2002

17. Risk factors for microalbuminuria and its relations with metabolic syndrome: the Ericabel study

Author

UCL - (SLuc) Service de néphrologie, VAN BIESEN, W., Jadoul, Michel, VERBEELEN, D., KRZESINSKI, J., TIELEMANS, C., VANHOLDER, R., WARRINNIER, H., DE VOS, L., World Congress of Nephrology, UCL - (SLuc) Service de néphrologie, VAN BIESEN, W., Jadoul, Michel, VERBEELEN, D., KRZESINSKI, J., TIELEMANS, C., VANHOLDER, R., WARRINNIER, H., DE VOS, L., and World Congress of Nephrology

Published
2009

18. [Does the biocompatibility of the hemodialysis membrane influence the prognosis of acute renal insufficiency?]

Author

Tielemans C, Gastaldello K, Christian MELOT, Rj, Kahn, and Jl, Vanherweghem

Subjects
Renal Dialysis, Humans, Biocompatible Materials, Membranes, Artificial, Acute Kidney Injury, Cellulose, Prognosis
Abstract

Several recent publications have suggested that the use of cuprophane in the setting of acute renal failure is associated with a higher mortality (especially from sepsis) and a slower recovery of renal function in the survivors in comparison with more biocompatible membranes. We present here a critical review of these publications and point to several methodological bias that might invalidate their conclusions. However, while waiting further information, we would advocate to abandon the use of cuprophane to dialyze patients with acute renal failure.

Published
1998

21. Effect of a plasma sodium biofeedback system applied to HFR on the intradialytic cardiovascular stability. Results from a randomized controlled study

Author

Locatelli, F., primary, Stefoni, S., additional, Petitclerc, T., additional, Coli, L., additional, Di Filippo, S., additional, Andrulli, S., additional, Fumeron, C., additional, Frasca, G. M., additional, Sagripanti, S., additional, Savoldi, S., additional, Serra, A., additional, Stallone, C., additional, Aucella, F., additional, Gesuete, A., additional, Scarlatella, A., additional, Quarello, F., additional, Mesiano, P., additional, Ahrenholz, P., additional, Winkler, R., additional, Mandart, L., additional, Fort, J., additional, Tielemans, C., additional, and Navino, C., additional

Published
2012
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25. Lipid and apoprotein changes during atorvastatin up-titration in hemodialysis patients with hypercholesterolemia: a placebo-controlled study

Author

Lins, R.L., primary, Matthys, K.E., additional, Billiouw, J.M., additional, Dratwa, M., additional, Dupont, P., additional, Lameire, N.H., additional, Peeters, P.C., additional, Stolear, J.-C., additional, Tielemans, C., additional, Maes, B., additional, Ducobu, G.A. Verpooten J., additional, and Carpentier, Y.A., additional

Published
2004
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26. Rapidly Progressive Interstitial Renal Fibrosis in Young-women - Association With Slimming Regimen Including Chinese Herbs

Author

UCL - Cliniques universitaires Saint-Luc, UCL, Vanherweghem, JL., Jadoul, Michel, Depierreux, M., Tielemans, C., Abramowicz, D., Dratwa, M., Richard, C., Vandervelde, D., Verbeelen, D., Vanhaelenfastre, R., Vanhaelen, M., UCL - Cliniques universitaires Saint-Luc, UCL, Vanherweghem, JL., Jadoul, Michel, Depierreux, M., Tielemans, C., Abramowicz, D., Dratwa, M., Richard, C., Vandervelde, D., Verbeelen, D., Vanhaelenfastre, R., and Vanhaelen, M.

Abstract

Two similar cases of rapidly progressive fibrosing interstitial nephritis in young women who followed the same slimming regimen prompted us to conduct an epidemiological survey of the nephrology centres of Brussels and to further investigate the exact nature of this slimming treatment. Seven other women under the age of 50 in terminal or preterminal renal failure were admitted for dialysis in 1991 and 1992. They had all followed a slimming regimen in the same medical clinic. Renal biopsy samples in eight of the nine cases showed extensive interstitial fibrosis without glomerular lesions. Two of the patients were seen for the first time in terminal renal failure and were started immediately on dialysis. For the seven other women, the nephropathy was characterised by a rapid deterioration in renal function, with initial serum creatinine doubling within about 3 months. The clinic had specialised in slimming treatments for the previous 15 years without any problems. In May, 1990, therapy was changed, with the introduction of two Chinese herbs (Stephania tetrandra and Magnolia officinalis). In June, 1992, three of twenty-five randomly selected women who had followed the same regimen during at least 3 months from 1990 had impaired renal function. Chemical analysis of some brands of these Chinese herbs did not show nephrotoxic contaminants of fungal or plant origin (ochratoxin or aristolochic acid) or adulteration by diuretics or antiinflammatory drugs. However, the medicinal preparation of the capsules taken by patients had different alkaloid profiles from those expected in Chinese plants. The striking relation between a specific type of fibrosing interstitial nephritis in young women and a slimming treatment involving Chinese herbs adds support to the arguments against uncontrolled therapy with herbal preparations.

Published
1993

34. ACE inhibitors and anaphylactoid reactions to high-flux membrane dialysis

Author

Dinarello, CharlesA., primary, Alvarez-Lara, M.A., additional, Martin-Malo, A., additional, Espinosa, M., additional, Castillo, D., additional, Aljama, P., additional, Tielemans, C., additional, Vanherweghem, J.L., additional, Blumberg, A., additional, Cuvelier, R., additional, De Fremont, J.F., additional, Dehout, F., additional, Dupont, P., additional, Richard, C., additional, Stolear, J.C., additional, and Wens, R., additional

Published
1991
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35. Are standards for dialysate purity in hemodialysis insufficiently strict?

Author

Tielemans, Christian, Tielemans, C, Hoenich, N A, Levin, N W, Lonnemann, G, Favero, M S, and Schiffl, H

Subjects
*HEMODIALYSIS, *DIALYSIS (Chemistry)
Abstract

Examines whether standards for dialysate purity in hemodialysis is insufficiently strict. Ultrapure dialysis fluid and cytokine production in clinical dialysis; Ultrapure dialysis fluid and dialysis-related arnyloidosis; Response of ultrapure dialysis fluid to recombinant human erythroprotein.

Published
2001
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38. Effect of Recombinant Human Erythropoietin Therapy on Ambulatory Blood Pressure and Heart Rate in Chronic Haemodialysis Patients.

Author

van de Borne, P., Tielemans, C., Vanherweghem, J.-L., and Degaute, J.-P.

Abstract

Systemic hypertension as assessed by casual blood pressure measurements is a frequently reported side-effect of recombinant human erythropoietin (rHuEpo) treatment. We investigated the effect of rHuEpo treatment on the 24-h ambulatory blood pressure and heart rate profiles of 13 chronic haemodialysis patients. After 3–4 months of rHuEpo therapy it was found that the mean haematocrit had increased from 24.5± 1.0% to 32.0± 1.1% (<0.005), while body-weight and control of uraemia as assessed by routine laboratory data remained unchanged. Despite gradual and incomplete correction of anaemia by use of low doses of rHuEpo, increases in the ambulatory systolic and diastolic blood pressure were found. The greatest increases affected day-time systolic blood pressure and night-time diastolic blood pressure, and these increases were significant (<0.05). As a result, pulse pressure increased during day-time (<0.05) while the nighttime decline in diastolic blood pressure disappeared. An increase in peripheral resistance after partial correction of renal anaemia might explain these observations. rHuEpo therapy increased the percentage of abnormal ambulatory blood pressure measurements (defined as systolic blood pressure>140 mmHg and/or diastolic blood pressure >90 mmHg) from 33% to 52% (P<0.05) while in contrast, mean casual prehaemodialytic and posthaemodialytic blood pressure values remained unchanged. We conclude that changes in 24-h blood pressure profiles should be carefully assessed by ambulatory blood pressure monitoring in haemodialysis patients treated with rHuEpo, since these changes are likely to be missed when only causal blood pressures are measured. [ABSTRACT FROM PUBLISHER]

Published
1992

39. Critical Role of Iron Overload in the Increased Susceptibility of Haemodialysis Patients to Bacterial Infections. Beneficial Effects of Desferrioxamine.

Author

Tielemans, C. L., Lenclud, C. M., Wens, R., Collart, F. E., and Dratwa, M.

Abstract

Iron overload, which is a common complication in haemodialysis patients, is known to enhance bacterial growth and virulence, and to alter phagocytosis. We reviewed the data of 61 haemodialysed patients to clarify the clinical relevance of iron status to the risk of bacterial infection. Increased concentrations of serum ferritin were associated with a greater infection rate (<0.0025), which was already true for ferritin values between 500 and l000μ/l (.<0.025). Furthermore, in 21 iron-overloaded patients treated with an iron-chelator (desferrioxamine), the infection rate decreased from 1/19 patient-months to 1/112 (<0.005), and returned to previous values when desferrioxamine was stopped. Our results demonstrate the importance of haemosiderosis in the increased susceptibility of haemodialysed patients to infections; this susceptibility is decreased by desferrioxamine therapy, which probably acts by restoring phagocytosis and reducing the bioavailability of iron for pathogens. [ABSTRACT FROM PUBLISHER]

Published
1989

40. Continuous Ambulatory Peritoneal Dialysis vs Haemodialysis: A Lesser Risk of Amyloidosis?

Author

Tielemans, C., Dratwa, M., Bergmann, P., Goldman, M., Flamion, B., Collart, F., and Wens, R.

Abstract

We compared plasma beta-2-microglobulin βM at a 1-year interval in 25 CAPD patients and 25 patients haemodialysed with cuprophane membranes and matched for residual renal function and duration of renal replacement therapy. Plasma βM remained lower in CAPD patients throughout the study, and increased significantly with time both in CAPD and haemodialysis patients, as renal function decreased. In both groups, plasma βM was negatively correlated with residual creatinine clearance, the influence of the latter being much greater in haemodialysis, as demonstrated by comparison of the regression lines. In haemodialysis, but not in CAPD. plasma βM also correlated with time on dialysis. In CAPD patients. the daily peritoneal output averaged 38 mg (range 16–59 mg), and was directly correlated with plasma βM CAPD thus allows a significant peritoneal removal of βM which progressively takes over from the declining renal function, resulting in lower plasma βM than in matched haemodialysis patients. However, the peritoneal removal of βM remains insufficient and values increase with time as renal function declines. Thus, if βM amyloidosis is related to raised plasma levels, the risk of βM amyloidosis in CAPD should simply be delayed as compared to haemodialysis. [ABSTRACT FROM PUBLISHER]

Published
1988

43. Role of complement and platelet-activating factor in the stimulation of phagocytosis and reactive oxygen species production during haemodialysis.

Author

Gastaldello, K, Husson, C, Wens, R, Vanherweghem, J L, and Tielemans, C

Abstract

Neutrophil phagocytic functions have been studied extensively in haemodialysis (HD) patients; however, results are contradictory and the mechanisms that modulate phagocytosis and oxidative burst during dialysis are not completely understood.

Published
2000
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44. Comparison of cellulose diacetate and polysulfone membranes in the outcome of acute renal failure. A prospective randomized study.

Author

Gastaldello, K, Melot, C, Kahn, R J, Vanherweghem, J L, Vincent, J L, and Tielemans, C

Abstract

Whether the nature of haemodialysis (HD) membranes can influence the outcome of acute renal failure (ARF) remains debatable. Recent studies have suggested that dialysis with bioincompatible unsubstituted cellulosic membranes is associated with a less favourable patient outcome than dialysis with biocompatible synthetic membranes. Since we generally use a modified cellulosic membrane with substantially lower complement- and leukocyte-activating potential than cuprophane, for dialysis of patients with ARF, and because there are no data in the literature regarding the influence of modified cellulosic membranes on the outcome of patients with ARF, we compared the outcome of ARF patients dialysed either with cellulose diacetate or with a synthetic polysulfone membrane. We also investigated the potential role of permeability by comparing membranes with high-flux versus low-flux characteristics.

Published
2000
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46. High haematocrit in haemodialysis patients can be controlled by theophylline administration.

Author

Vereerstraeten, A., Gastaldello, K., Gervy, C., Vanherweghem, J-L., and Tielemans, C.

Abstract

Three patients on chronic maintenance haemodialysis have progressively increased their haematocrit to reach values between 40 and 45%, a situation associated with an increased risk of thrombosis of their arteriovenous fistulae. Two of them had been submitted to repeated phebotomies, which remained unsuccessful despite the induction of a profound iron deficiency in one of them. Hence, a trial with oral theophylline was performed in the three patients, resulting in a sustained decrease of the haematocrit (from 43.6 to 33%) and endogenous erythropoietin (from 46 to 15 mU/ml) levels. In two patients, theophylline therapy was stopped transiently due to gastrointestinal side-effects, which resulted in a rapid return to previous haematocrit levels; rechallenge with a better tolerated preparation, however, was efficient again. We conclude that oral theophylline appears to be an efficient treatment to control too high haematocrit levels in dialysis patients. [ABSTRACT FROM PUBLISHER]

Published
1994

47. Effect of aluminum on porphyrin metabolism in hemodialyzed patients

Author

UCL - MD/ESP - Ecole de santé publique, UCL - (SLuc) Service d'anatomie pathologique, UCL - (SLuc) Centre de toxicologie clinique, Buchet, Jean-Pierre, Lauwerys, Robert, Hassoun, A., Dratwa, M., Wens, R., Collart, F., Tielemans, C., UCL - MD/ESP - Ecole de santé publique, UCL - (SLuc) Service d'anatomie pathologique, UCL - (SLuc) Centre de toxicologie clinique, Buchet, Jean-Pierre, Lauwerys, Robert, Hassoun, A., Dratwa, M., Wens, R., Collart, F., and Tielemans, C.

Abstract

In patients with renal failure and on chronic hemodialysis, serum aluminum, serum delta-aminolevulinic acid, serum porphobilinogen and erythrocyte zinc protoporphyrin (ZPP) are significantly elevated, whereas erythrocyte delta-aminolevulinic acid dehydratase activity (ALAD, values in percent) is significantly reduced. The last two parameters (ZPP and ALAD) are statistically related to serum aluminum concentration (Al-S), but only the correlation between Al-S and ALAD remains statistically significant after standardization for the degree of renal insufficiency (expressed in terms of urea level). This study does not support the hypothesis that the retention of aluminum is responsible for the increase of ZPP in uremic patients on dialysis. The disturbances of porphyrin metabolism found in patients with renal failure and on chronic dialysis are not similar to those observed in porphyria cutanea tarda.

Published
1987

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