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2. 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., 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., Hubel E., Frischmuth N., Liebl R., Fiedler R., Schwenger V., Vosskuhler A., Kunzendorf U., Renders L., Rattensberger D., Rump L., Ketteler M., Neumayer H., Zantvoort F., Stahl R., Ladanyi E., 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., Kazup 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., Frasca 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., Aranda Verastegui F., Pena J., Chew Wong A., Cruz-Valdez J., Torres Zamora M., Solis M., Sebastian Diaz M., Vital Flores M., Alvarez Sandoval E., Van Den Dorpel M., Brink H., Van Kuijk W., Vermeij C., Smak 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., 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 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. 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., 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., 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., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., 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., Kazup 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., Frasca, 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., Aranda Verastegui, F., Pena, J., Chew Wong, A., Cruz-Valdez, J., Torres Zamora, M., Solis, M., Sebastian Diaz, M., Vital Flores, M., Alvarez Sandoval, E., Van Den Dorpel, M., Brink, H., Van Kuijk, W., Vermeij, C., Smak 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., 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, 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. 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

3. The effects of cinacalcet in older and younger patients on hemodialysis: The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial

Author

P. Ryckelynck, Y. Woredekal, T. Gehr, Marian Klinger, J. Passauer, K. Liss, E. Del Valle, B. Linares, Ferdinando Avella, Stolear Jc, S. Tolkan, O. Hermida, V. Wizemann, Ricardo Correa-Rotter, J. Santos, Gert Mayer, Michael Anger, B. Pellegrino, B. Wikström, A. Ståhl, H. Al-Bander, Pedro Alejandro Gordan, Philip A. Kalra, E. Galindo-Ramos, Carmine Zoccali, G. Dolson, M. Eigner, Sanjay Dalal, G. Touchard, J Peeters, G. Da Roza, Shannon Murphy, R. Errico, M. Lonergan, A. Andrusev, H. Boulechfar, P. Zaoui, Michael Suranyi, de Francisco Martín de Francisco, S. Jacobson, B. Gupta, C. Stafford, J. Picollo de Oliveira, Ilka Regina Souza de Oliveira, F. Dumler, J. Martinez Saye, E. de Almeida Romão, Emmanuel A. Burdmann, C. Vermeij, N. Kumar, E. Shahmir, J. Stratton, R. Schmidt, Mario Cozzolino, Lars Christian Rump, Rainer Oberbauer, J. Kumar, M. Saklayen, Brian Hutchison, C. Denu-Ciocca, L. Weiss, E. Friedman, L. Renders, K. Gurevich, L. Brandi, W. Shapiro, Kym M. Bannister, K. Berta, Muhammad M. Yaqoob, C. Lok, A. Pedrosa, Rosa M.A. Moysés, K. Bhandari, J. Arrieta, T. Crouch, Brigitte Maes, G. Wong, Myriam González, Matthew R. P. Davies, R. Gonzalez, Geoffrey A. Block, T. Nammour, T. Youell, J. Ramirez, S. Tobe, N. Ramirez, T. Bochicchio-Ricardelli, J. Cangiano-Rivera, D. Streja, J. Endsley, K. Ang, R. Patak, J. Cheng, T. Rogers, Alberto Albertazzi, H. Holzer, G. Choukroun, Jose A.L. Arruda, Philippe Rieu, P. Simon, Stephen Z. Fadem, Jared G. Sugihara, H. Alfred, Bruce F. Culleton, G. Frascà, Giovanni Pertosa, W. Van Kuijk, H. Beresan, Samuel S. Blumenthal, Piergiorgio Messa, H. Baer, Michael C. Braun, B. Rutkowski, W. Riegel, M. Komandenko, V. Ermolenko, Martin Wilkie, N. Muirhead, Peter G. Kerr, D. Rattensberger, J. Sabto, Anjay Rastogi, L. Lef, M. El Shahawy, D. Tharpe, A. Smirnov, J. Pons, F. García, F. Zantvoort, A. Lionet, J. Topf, Marcia R. Silver, Reinhard Kramar, E. Moriero, A. Rekhi, S. Roe, P. Batista, E. Kolmakova, F. Rahim, M. Ostrowski, Janice P. Lea, Patrizia Ondei, C. Martinez, J. Donck, Nicole Lopez, F. Schena, Allen R. Nissenson, Alex P.S. Disney, R. Valtuille, C. Najun Zarazaga, M. Fraenkel, Pieter Evenepoel, R. Cottiero, S. Di Giulio, V. Gura, S. Karunakaran, P. Nader, F. Saldanha Thome, Walter Douthat, A. Fekete, L. Arbeit, W. Sulowicz, I. Marin, Charles R.V. Tomson, Andrzej Wiecek, Luis A. Juncos, G. Mingardi, P. Light, Max Dratwa, H. Reichel, R. Raja, U. Ranjit, G. Sterner, E. Coll Piera, P. Pai, Robert J. Walker, R. Bregman, E. Hübel, M. Timofeev, T. Szabo, A. Elli, N. Padmanabhan, N. Garrote, M. Mysliwiec, David C. Wheeler, J. Cruz-Valdez, R. Klauser, Maree-Ross Smith, Antonio Carlos Carvalho, A. Losito, M. Durlik, G. Petraglia, Gianni Cappelli, Y. Lien, M. Chaffin, N. García, R. Halligan, Glenn M. Chertow, M. Bastos, P. Smak Gregoor, S. Ong, M. Belledonne, Fredric O. Finkelstein, J. Martínez García, R. Pecoits Filho, M. Klingberg, B. Carvalho, S. Noble, T. Plumb, A. 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Subjects
Parathyroidectomy, Adult, Male, medicine.medical_specialty, Cinacalcet, Epidemiology, medicine.medical_treatment, Calcimimetic Agents, Critical Care and Intensive Care Medicine, Lower risk, Severity of Illness Index, CKD, cardiovascular disease, hemodialysis, hyperparathyroidism, mineral metabolism, Age Factors, Aged, Aged, 80 and over, Cardiovascular Diseases, Cinacalcet Hydrochloride, Female, Humans, Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Kidney Transplantation, Middle Aged, Renal Dialysis, Nephrology, Transplantation, Internal medicine, medicine, Intensive care medicine, Hyperparathyroidism, business.industry, Original Articles, medicine.disease, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug
Abstract

Background andobjectivesThecalcimimeticcinacalcet reduced therisk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older ($65 years, n=1005) and younger (,65 years, n=2878) patients. Design, setting, participants, & measurements Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified. ResultsOlderpatients hadhigher baselineprevalenceof diabetesmellitusandCV comorbidity. Annualizedrates of kidney transplantation and parathyroidectomy were .3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups. Conclusions In the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone. Clin J Am Soc Nephrol 10: ccc–ccc, 2015. doi: 10.2215/CJN.07730814

Published
2015

4. Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease.

Author

Girndt M, Houser P, Manllo-Karim R, Ervin JE, Charytan C, Chow S, Symonian-Silver M, Lehrner L, Linfert D, Shemin D, Michelsen A, Xie F, and Janssen RS

Subjects
Male, Humans, Adult, Aged, Female, Hepatitis B Vaccines, Hepatitis B Surface Antigens, Hepatitis B virus, Hepatitis B Antibodies, Endoglin, Hepatitis B prevention & control, Renal Insufficiency, Chronic complications, Renal Insufficiency, Chronic therapy
Abstract

Background: Hepatitis B virus (HBV) infection remains a significant global burden, especially for patients with chronic kidney disease (CKD) receiving hemodialysis. Three doses of HepB-CpG (HEPLISAV-B® vaccine) induced a superior immune response compared with 4 double doses of HepB-Eng (Engerix-B®) in a phase 3 trial (HBV-17) in adults with CKD. Here we report the long-term immunogenicity and safety of HepB-CpG and HepB-Eng in eligible participants of HBV-17 who enrolled in this optional 34-month follow-up trial (HBV-19)., Methods: HBV-19 is a multicenter, open-label, phase 3b trial of adults with CKD who previously received a complete series of HepB-CpG or HepB-Eng in the HBV-17 trial. Participants were assigned to seroprotection categories at enrollment on the basis of their antibody response to hepatitis B surface antigen (anti-HBs) in HBV-17. The objective was to evaluate the durability of seroprotection (defined as an anti-HBs concentration ≥ 10mIU/mL) induced by HepB-CpG and HepB-Eng. Participants whose anti-HBs concentration was below 10mIU/mL received additional HepB-CpG or HepB-Eng doses., Results: 147 participants were enrolled; 66.7 % were men, median age was 65.0 years, and 83.7 % were white. The durability of seroprotection in participants with CKD was similar in those who received HepB-CpG and those who received HepB-Eng. Antibody concentrations ≥ 100mIU/mL persisted for longer in HepB-CpG than HepB-Eng recipients, among those with anti-HBs ≥ 100mIU/mL post vaccination. The geometric mean anti-HBs concentration in the HepB-CpG group was significantly higher than in the HepB-Eng group over time (P ≤ 0.0001). The safety profiles were similar between the vaccine groups., Conclusions: Due to the higher antibody levels induced by HepB-CpG in participants with CKD, seroprotection against HBV may be expected to persist longer than that induced by HepB-Eng., Clinicaltrials: gov: NCT01282762., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: M.G. received speaker's honoraria from Astellas, Daiichi Sankyo, Novartis, Sanofi, Vifor, and GlaxoSmithKline unrelated to the topic of this work. F.X. is a consultant for and R.S.J. is an employee of Dynavax Technologies Corporation. No other conflicts were reported., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2023
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5. Changes in Iron Availability with Roxadustat in Nondialysis- and Dialysis-Dependent Patients with Anemia of CKD.

Author

Pergola PE, Charytan C, Little DJ, Tham S, Szczech L, Leong R, and Fishbane S

Subjects
Humans, Epoetin Alfa metabolism, Ferritins therapeutic use, Glycine analogs & derivatives, Hemoglobins analysis, Hepcidins, Iron therapeutic use, Isoquinolines, Renal Dialysis, Randomized Controlled Trials as Topic, Clinical Trials, Phase III as Topic, Anemia drug therapy, Erythropoietin metabolism, Prolyl-Hydroxylase Inhibitors therapeutic use, Renal Insufficiency, Chronic complications
Abstract

Background: Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, increases hemoglobin by stimulating erythropoietin synthesis and improving iron availability through facilitation of iron uptake and/or release from stores. In this exploratory analysis, we assessed the effect of roxadustat treatment on laboratory parameters related to iron metabolism in patients with anemia of chronic kidney disease (CKD)., Methods: Data were pooled from pivotal, randomized, phase 3 roxadustat trials: three placebo-controlled, double-blind trials in nondialysis-dependent (NDD) CKD and three open-label, active-comparator (epoetin alfa) trials in dialysis-dependent (DD) CKD. In this exploratory analysis, mean changes from baseline in hemoglobin, iron parameters, and hepcidin, and intravenous (iv) iron use were evaluated. Pooled results in NDD CKD and DD CKD patients are reported., Results: Overall, 4277 patients with NDD CKD and 3890 patients with DD CKD were evaluated. Hemoglobin increases with roxadustat treatment were accompanied by increases in serum iron and total iron-binding capacity (TIBC) and decreases in serum ferritin and hepcidin from baseline through week 52. With epoetin alfa, the hemoglobin increase was accompanied by decreases in serum ferritin and hepcidin, but serum iron decreased, and there was no change in TIBC. With placebo, there were no changes in hemoglobin, iron parameters, or hepcidin. During treatment, iv iron use was reduced with roxadustat versus placebo and epoetin alfa., Conclusions: In patients with NDD CKD and DD CKD, roxadustat treatment is associated with increases in serum iron and TIBC, accompanied by reduced hepcidin and indicative of improved iron kinetics. Patients treated with roxadustat achieved target hemoglobin levels with less iv iron use versus comparators. Practitioners treating patients with anemia of CKD with roxadustat should consider its unique effects when interpreting iron parameters., Competing Interests: S. Fishbane and P.E. Pergola have received research support and consulting fees from AstraZeneca. D.J. Little and S. Tham are employees of AstraZeneca. R. Leong and L. Szczech are former employees of FibroGen, Inc. C. Charytan has received research support from AstraZeneca and FibroGen, Inc., (Copyright © 2022 by the American Society of Nephrology.)

Published
2022
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6. A Randomized Trial of Roxadustat in Anemia of Kidney Failure: SIERRAS Study.

Author

Charytan C, Manllo-Karim R, Martin ER, Steer D, Bernardo M, Dua SL, Moustafa MA, Saha G, Bradley C, Eyassu M, Leong R, Saikali KG, Liu C, Szczech L, and Yu KP

Abstract

Introduction: Erythropoiesis-stimulating agents, standard of care for anemia of end-stage kidney disease, are associated with cardiovascular events. We evaluated the efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis., Methods: SIERRAS was a phase 3, randomized, open-label, active-controlled study enrolled adults on dialysis for end-stage kidney disease receiving erythropoiesis-stimulating agents for anemia. Patients were randomized (1:1) to thrice-weekly roxadustat or epoetin alfa. Doses were based on previous epoetin alfa dose and adjusted in the roxadustat arm to maintain hemoglobin at ∼11 g/dl during treatment. Epoetin alfa dosing was adjusted per US package insert. Primary efficacy endpoint was mean hemoglobin (g/dl) change from baseline averaged over weeks 28 to 52. Treatment-emergent adverse events were monitored., Results: Enrolled patients (roxadustat, n  = 370 and epoetin alfa, n  = 371) had similar mean (SD) baseline hemoglobin levels (10.30 [0.66] g/dl). Mean (SD) hemoglobin changes for weeks 28 to 52 were 0.39 (0.93) and -0.09 (0.84) in roxadustat and epoetin alfa, respectively. Roxadustat was noninferior (least squares mean difference: 0.48 [95% confidence interval: 0.37, 0.59]; P  < 0 . 001) to epoetin alfa. Tolerability was comparable between treatments., Conclusion: In end-stage kidney disease, roxadustat was noninferior to epoetin alfa in up to 52 weeks of treatment in this erythropoietin-stimulating agent conversion study. Roxadustat had an acceptable tolerability profile., (© 2021 International Society of Nephrology. Published by Elsevier Inc.)

Published
2021
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7. Optimizing Kidney Replacement Therapy During the COVID-19 Pandemic Across a Complex Healthcare System.

Author

Akomeah J, Apostol A, Barnes E, Charytan C, Enriquez U, Katikaneni M, Liu F, Messina A, Neelakantappa K, Radhakrishnan J, Raichoudhury R, Ramakrishnan R, Saboor S, Sapozhnikova A, Silberzweig J, Stevens JS, Tanzi-Pfeifer S, Tutone J, and Srivatana V

Abstract

The unprecedented surge of nephrology inpatients needing kidney replacement therapy placed hospital systems under extreme stress during the COVID-19 pandemic. In this article, we describe the formation of a cross campus "New-York Presbyterian COVID-19 Kidney Replacement Therapy Task Force" with intercampus physician, nursing, and supply chain representation. We describe several strategies including the development of novel dashboards to track supply/demand of resources, urgent start peritoneal dialysis, in-house preparation of kidney replacement fluid, the use of unconventional personnel resources to ensure the safe and continued provision of kidney replacement therapy in the face of the unanticipated surge. These approaches facilitated equitable sharing of resources across a complex healthcare-system and allowed for the rapid implementation of standardized protocols at each hospital., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2020 Akomeah, Apostol, Barnes, Charytan, Enriquez, Katikaneni, Liu, Messina, Neelakantappa, Radhakrishnan, Raichoudhury, Ramakrishnan, Saboor, Sapozhnikova, Silberzweig, Stevens, Tanzi-Pfeifer, Tutone and Srivatana.)

Published
2020
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8. Pernicious Anemia Associated Cobalamin Deficiency and Thrombotic Microangiopathy: Case Report and Review of the Literature.

Author

Yousaf F, Spinowitz B, Charytan C, and Galler M

Abstract

A 43-year-old Hispanic male without significant previous medical history was brought to emergency department for syncope following a blood draw to investigate a 40 lbs weight loss during the past 6 months associated with decreased appetite and progressive fatigue. The patient also reported a 1-month history of jaundice. On examination, he was hemodynamically stable and afebrile with pallor and diffuse jaundice but without skin rash or palpable purpura. Normal sensations and power in all extremities were evident on neurological exam. Presence of hemolytic anemia, schistocytosis, thrombocytopenia, and elevated lactate dehydrogenase (LDH) was suggestive of thrombotic thrombocytopenic purpura (TTP). However, presence of leukopenia, macrocytes, and an inadequate reticulocyte response to the degree of anemia served as initial clues to an alternative diagnosis. Two and one units of packed red blood cells were transfused on day 1 and day 3, respectively. In addition, one unit of platelets was transfused on day 2. Daily therapeutic plasma exchange (TPE) was initiated and continued until ADAMTS-13 result ruled out TTP. A low cobalamin (vitamin B12) level was evident at initial laboratory work-up and subsequent testing revealed positive intrinsic factor-blocking antibodies supporting a diagnosis of pernicious anemia with severe cobalamin deficiency. Hematological improvement was observed following vitamin B12 supplementation. The patient was discharged and markedly improved on day 9 with outpatient follow-up for cobalamin supplementation., Competing Interests: The authors declare that they have no competing interests and that the results presented have not been published previously in whole or part, except in abstract format.

Published
2017
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9. Introduction of Biosimilar Therapeutics Into Nephrology Practice in the United States: Report of a Scientific Workshop Sponsored by the National Kidney Foundation.

Author

Wish JB, Charytan C, Chertow GM, Kalantar-Zadeh K, Kliger AS, Rubin RJ, Yee J, and Fishbane S

Subjects
Biomedical Research, Congresses as Topic, Drug Utilization, Humans, Kidney Diseases drug therapy, Practice Guidelines as Topic, United States, Biosimilar Pharmaceuticals therapeutic use, Nephrology
Abstract

Biosimilars are biologic medicines highly similar to the reference product with no meaningful clinical differences in terms of safety, purity, and potency. All biologic medicines are produced by living cells, resulting in an inherent heterogeneity in their higher order structures and post-translational modifications. In 2010, the US Congress enacted legislation to streamline the approval process for biosimilars of products losing patent protection, with the goal of decreasing costs and improving patient access to therapeutically important but expensive biologic agents. In 2015, the US Food and Drug Administration approved the first biosimilar agent through this pathway. Approval of additional biosimilar agents in the United States, including those used by nephrologists, is anticipated. Given the relative lack of knowledge regarding biosimilars and their approval process and a lack of trust by the nephrology community regarding their safety and efficacy, the National Kidney Foundation conducted a symposium, Introduction of Biosimilar Therapeutics Into Nephrology Practice in the U.S., September 17 to 18, 2015. Issues related to manufacturing, the regulatory approval process, interchangeability, substitution/switching, nomenclature, and clinician and patient awareness and acceptance were examined. This report summarizes the main discussions at the symposium, highlights several controversies, and makes recommendations related to public policy, professional and patient education, and research needs., (Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Published
2016
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10. Systematic review of the efficacy and safety of intradermal versus intramuscular hepatitis B vaccination in end-stage renal disease population unresponsive to primary vaccination series.

Author

Yousaf F, Gandham S, Galler M, Spinowitz B, and Charytan C

Subjects
Humans, Injections, Intradermal, Injections, Intramuscular, Hepatitis B prevention & control, Hepatitis B Surface Antigens blood, Hepatitis B Vaccines administration & dosage, Kidney Failure, Chronic immunology, Vaccination methods
Abstract

Introduction: The response to hepatitis B vaccine in the dialysis population is reduced compared to the general population. The intradermal (ID) hepatitis B vaccine has been studied as a potential alternative to intramuscular (IM) administration. This alternative route of administration may illicit a response via a distinct immunologic pathway that may help achieve higher seroconversion rates and thus, protection against hepatitis B infection in this vulnerable patient population., Methods: A literature search was performed in January 2015 using Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials with keywords including, hepatitis B vaccines, intradermal, dermal, intracutaneous, dialysis, hemodialysis, continuous ambulatory peritoneal dialysis, CAPD, peritoneal dialysis, renal failure, chronic renal failure, chronic kidney disease, chronic renal insufficiency, End Stage Renal Disease, ESRD, and CKD. Our search strategy was restricted to human studies published in the English language, and additional literature was retrieved by hand-searching bibliographies of relevant articles. Two reviewers (F.Y. and S.G.) independently reviewed abstracts and/or full texts of articles retrieved from the electronic database using the above-mentioned search strategy. Inclusion criteria were as follows: (1) Published, English-language studies performed in the human population, (2) adult patient population (≥18 years of age), (3) randomized trials, (4) patient population must have been unresponsive to a primary IM hepatitis B vaccination protocol, (5) patients must be chronic dialysis patients, either on maintenance hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), (6) studies that compare IM and ID hepatitis B vaccination-associated seroconversion rates, (7) results must be reported as seroconversion rates at 1-3, 6-9, 12, or 20 months post-vaccination, and (8) seroconversion (protective antibody levels) defined as >10 or ≥10 IU/L., Results: Our initial literature review yielded 113 results, of which four were included in our final review. These four prospective trials studied a combined total of 204 dialysis patients. Of these patients, 120 (59%) had received the hepatitis B vaccine intradermally, while 84 (41%) received it intramuscularly. Hepatitis B vaccination type, dose, route, and seroconversion rates were tabulated for each study. Each of the studies used different protocols for patient inclusion, schedule of vaccine administration, and time-points for measuring seroconversion. Seroconversion rates at either 1, 2, 3, 6-9, 12 and/or 20 months were reported. The combined seroconversion rates were 91%, 83%, 86%, 81%, 76%, and 32% at 1, 2, 3, 6-9, 12, and 20 months in the ID group, respectively, and 55%, 72%, 58%, 44%, 24%, and 0% in the IM group, respectively. Chi-square analysis revealed a significantly higher proportion of patients achieving seroconversion in the ID group versus the IM group (p < 0.05)., Conclusions: Our review demonstrates that ID hepatitis B vaccination in primary non-responders undergoing dialysis provides an effective alternative to IM vaccination as a means of protection against hepatitis B infection in this highly susceptible population. Additional well-designed, double-blinded, randomized trials are warranted to establish clear guidelines on ID Hepatitis B vaccine dose and duration of vaccination schedule.

Published
2015

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