8 results on '"Rubis N."'
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2. Mesenchymal Stem/Stromal Cells: INTERIM REPORT FROM THE NEPHSTROM MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE-1B CLINICAL TRIAL OF A NOVEL MESENCHYMAL STROMAL CELL THERAPY IN PROGRESSIVE DIABETIC KIDNEY DISEASE
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Griffin, M., primary, Perico, N., additional, Cockwell, P., additional, Maxwell, P., additional, Rubis, N., additional, Casiraghi, F., additional, Villa, A., additional, Ruggenenti, P., additional, Cappelletti, L., additional, McInerney, V., additional, Duffy, A., additional, Finnerty, A., additional, Smythe, J., additional, Pedrini, O., additional, Golay, J., additional, Introna, M., additional, Steeneveld, E., additional, Roelofs, H., additional, Fibbe, W., additional, Elliman, S.J., additional, Remuzzi, G., additional, and O’Brien, T., additional
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- 2022
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3. Effects of Sevelamer Carbonate in Patients With CKD and Proteinuria: The ANSWER Randomized Trial
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Ruggiero, Barbara, primary, Trillini, Matias, additional, Tartaglione, Lida, additional, Rotondi, Silverio, additional, Perticucci, Elena, additional, Tripepi, Rocco, additional, Aparicio, Carolina, additional, Lecchi, Veruska, additional, Perna, Annalisa, additional, Peraro, Francesco, additional, Villa, Davide, additional, Ferrari, Silvia, additional, Cannata, Antonio, additional, Mazzaferro, Sandro, additional, Mallamaci, Francesca, additional, Zoccali, Carmine, additional, Bellasi, Antonio, additional, Cozzolino, Mario, additional, Remuzzi, Giuseppe, additional, Ruggenenti, Piero, additional, Kohan, Donald E., additional, Perico, N., additional, Ruggenenti, P., additional, Remuzzi, G., additional, Ruggiero, B., additional, Trillini, M., additional, Aparicio, C., additional, Tartaglione, L., additional, Rotondi, S., additional, Prandini, S., additional, Lecchi, V., additional, Cugini, D., additional, Gherardi, G., additional, Zoccali, C., additional, Mallamaci, F., additional, Parlongo, G., additional, Panuccio, V., additional, Caridi, G., additional, Tripepi, R., additional, Rubis, N., additional, Diadei, O., additional, Villa, D., additional, Carminati, S., additional, Martinetti, D., additional, Giuliano, G.A., additional, Perna, A., additional, Peraro, F., additional, Celeste, A., additional, Gaspari, F., additional, Carrara, F., additional, Ferrari, S., additional, Stucchi, N., additional, Cannata, A., additional, Mazzaferro, S., additional, Fassino, V., additional, Boccardo, P., additional, and Peracchi, S., additional
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- 2019
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4. C5 Convertase Blockade in Membranoproliferative Glomerulonephritis: A Single-Arm Clinical Trial
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Ruggenenti, Piero, primary, Daina, Erica, additional, Gennarini, Alessia, additional, Carrara, Camillo, additional, Gamba, Sara, additional, Noris, Marina, additional, Rubis, Nadia, additional, Peraro, Francesco, additional, Gaspari, Flavio, additional, Pasini, Andrea, additional, Rigotti, Angelo, additional, Lerchner, Renelda M., additional, Santoro, Domenico, additional, Pisani, Antonio, additional, Pasi, Alessandra, additional, Remuzzi, Giuseppe, additional, Remuzzi, G., additional, Ruggenenti, P., additional, Mondo, E., additional, Rota, S., additional, Carrara, C., additional, Portalupi, V., additional, Pasini, A., additional, Monitini, G., additional, Monti, E., additional, Rigotti, A., additional, De Giovanni, F., additional, Giacon, B., additional, Lerchner, R.M., additional, Passler, W., additional, Santoro, D., additional, Visconti, L., additional, Pisani, A., additional, Riccio, E., additional, Pasi, A., additional, Dugo, M., additional, Tuono, C., additional, Emma, F., additional, Vivarelli, M., additional, Murer, L., additional, Benetti, E., additional, Coppo, R., additional, Amore, A., additional, Gambaro, G., additional, Passalacqua, S., additional, Ruggiero, B., additional, Daina, E., additional, Bresin, E., additional, Gamba, S., additional, Prandini, S., additional, Lecchi, V., additional, Cugini, D., additional, Gherardi, G., additional, Rubis, N., additional, Diadei, O., additional, Villa, A., additional, Villa, D., additional, Boccardo, P., additional, Peracchi, S., additional, Martinetti, D., additional, Perna, A., additional, Peraro, F., additional, Giuliano, G.A., additional, Gaspari, F., additional, Carrara, F., additional, Ferrari, S., additional, Stucchi, N., additional, Cannata, A., additional, Noris, M., additional, Bettoni, S., additional, Alberti, M., additional, Cuccarolo, P., additional, Rizzo, P., additional, Marchetti, G.F., additional, and Sonzogni, A., additional
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- 2019
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5. Long-term Effects of Octreotide on Liver Volume in Patients With Polycystic Kidney and Liver Disease
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Pisani, Antonio, primary, Sabbatini, Massimo, additional, Imbriaco, Massimo, additional, Riccio, Eleonora, additional, Rubis, Nadia, additional, Prinster, Anna, additional, Perna, Annalisa, additional, Liuzzi, Raffaele, additional, Spinelli, Letizia, additional, Santangelo, Michele, additional, Remuzzi, Giuseppe, additional, Ruggenenti, Piero, additional, Pisani, A., additional, Sabbatini, M., additional, Ruggenenti, P., additional, Remuzzi, G., additional, Visciano, B., additional, Amicone, M., additional, Dipietro, R., additional, Mozzillo, G., additional, Riccio, E., additional, Rossano, R., additional, Spinelli, L., additional, Santangelo, M., additional, Rubis, N., additional, Diadei, O., additional, Calini, W., additional, Villa, A., additional, Sabatella, M., additional, Ene-Iordache, B., additional, Carminati, S., additional, Martinetti, D., additional, Giuliano, G.A., additional, Perna, A., additional, Liuzzi, R., additional, Remuzzi, A., additional, Imbriaco, M., additional, Prinster, A., additional, Altiero, M., additional, Boccardo, P., additional, and Peracchi, S., additional
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- 2016
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6. C5 Convertase Blockade in Membranoproliferative Glomerulonephritis: A Single-Arm Clinical Trial
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Piero Ruggenenti, Erica Daina, Alessia Gennarini, Camillo Carrara, Sara Gamba, Marina Noris, Nadia Rubis, Francesco Peraro, Flavio Gaspari, Andrea Pasini, Angelo Rigotti, Renelda M. Lerchner, Domenico Santoro, Antonio Pisani, Alessandra Pasi, Giuseppe Remuzzi, G. Remuzzi, P. Ruggenenti, E. Mondo, S. Rota, C. Carrara, V. Portalupi, A. Pasini, G. Monitini, E. Monti, A. Rigotti, F. De Giovanni, B. Giacon, R.M. Lerchner, W. Passler, D. Santoro, L. Visconti, A. Pisani, E. Riccio, A. Pasi, M. Dugo, C. Tuono, F. Emma, M. Vivarelli, L. Murer, E. Benetti, R. Coppo, A. Amore, G. Gambaro, S. Passalacqua, B. Ruggiero, E. Daina, E. Bresin, S. Gamba, S. Prandini, V. Lecchi, D. Cugini, G. Gherardi, N. Rubis, O. Diadei, A. Villa, D. Villa, P. Boccardo, S. Peracchi, D. Martinetti, A. Perna, F. Peraro, G.A. Giuliano, F. Gaspari, F. Carrara, S. Ferrari, N. Stucchi, A. Cannata, M. Noris, S. Bettoni, M. Alberti, P. Cuccarolo, P. Rizzo, G.F. Marchetti, A. Sonzogni, Ruggenenti, P., Daina, E., Gennarini, A., Carrara, C., Gamba, S., Noris, M., Rubis, N., Peraro, F., Gaspari, F., Pasini, A., Rigotti, A., Lerchner, R. M., Santoro, D., Pisani, A., Pasi, A., Remuzzi, G., Mondo, E., Rota, S., Portalupi, V., Monitini, G., Monti, E., De Giovanni, F., Giacon, B., Passler, W., Visconti, L., Riccio, E., Dugo, M., Tuono, C., Emma, F., Vivarelli, M., Murer, L., Benetti, E., Coppo, R., Amore, A., Gambaro, G., Passalacqua, S., Ruggiero, B., Bresin, E., Prandini, S., Lecchi, V., Cugini, D., Gherardi, G., Diadei, O., Villa, A., Villa, D., Boccardo, P., Peracchi, S., Martinetti, D., Perna, A., Giuliano, G. A., Carrara, F., Ferrari, S., Stucchi, N., Cannata, A., Bettoni, S., Alberti, M., Cuccarolo, P., Rizzo, P., Marchetti, G. F., and Sonzogni, A.
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Adult ,Male ,medicine.medical_specialty ,C3 glomerulopathy ,C3GN (C3 glomerulonephritis) ,C5 blockade ,IC-MPGN (immune complex–mediated membranoproliferative glomerulonephritis) ,clinical trial ,eculizumab ,nephrotic syndrome ,proteinuria ,sC5b-9 (serum complement membrane attack complex) ,urinary protein excretion ,Adolescent ,Glomerulonephritis, Membranoproliferative ,C3 Glomerulonephritis ,030232 urology & nephrology ,Renal function ,Complement C3-C5 Convertases ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Interquartile range ,Internal medicine ,Membranoproliferative glomerulonephritis ,medicine ,Humans ,Prospective Studies ,030212 general & internal medicine ,Hypoalbuminemia ,Child ,Complement Activation ,Proteinuria ,business.industry ,Eculizumab ,medicine.disease ,Complement Inactivating Agents ,Nephrology ,Female ,medicine.symptom ,business ,Nephrotic syndrome ,medicine.drug - Abstract
Rationale & Objective: Primary membranoproliferative glomerulonephritis (MPGN) is a rare glomerulopathy characterized by complement dysregulation. MPGN progresses rapidly to kidney failure when it is associated with nephrotic syndrome. We assessed the effects of C5 convertase blockade in patients with MPGN and terminal complement activation. Study Design: Prospective off-on-off-on open-label clinical trial. Setting & Participants: Consenting patients with immune complex–mediated MPGN (n = 6) or C3 glomerulonephritis (n = 4) with sC5b-9 (serum complement membrane attack complex) plasma levels > 1,000 ng/mL and 24-hour proteinuria with protein excretion > 3.5 g identified from the Italian Registry of MPGN and followed up at the Istituto di Ricerche Farmacologiche Mario Negri IRCCS (Bergamo, Italy) between March 4, 2014, and January 7, 2015. Intervention: Anti-C5 monoclonal antibody eculizumab administered during 2 sequential 48-week treatment periods separated by one 12-week washout period. Outcomes: Primary outcome was change in 24-hour proteinuria (median of 3 consecutive measurements) at 24 and 48 weeks. Results: Median proteinuria decreased from protein excretion of 6.03 (interquartile range [IQR], 4.8-12.4) g/d at baseline to 3.74 (IQR, 3.2-4.4) g/d at 24 weeks (P = 0.01) and to 5.06 (IQR, 3.1-5.8) g/d (P = 0.006) at 48 weeks of treatment, recovered toward baseline during the washout period, and did not significantly decrease thereafter. Hypoalbuminemia, dyslipidemia, and glomerular sieving function improved during the first treatment period. 3 patients achieved partial remission of nephrotic syndrome and all had undetectable C3 nephritic factors before treatment. Mean measured glomerular filtration rate was 69.7 ± 35.2 versus 87.4 ± 55.1 and 75.8 ± 42.7 versus 76.6 ± 44.1 mL/min/1.73 m2 at the start versus the end of the first and second treatment periods, respectively, among all 10 study participants. Unlike C3, sC5b-9 plasma levels normalized during both treatment periods and recovered toward baseline during the washout in all patients. Limitations: Single-arm design, small sample size. Conclusions: Eculizumab blunted terminal complement activation in all patients with immune complex–mediated MPGN or C3 glomerulonephritis and nephrotic syndrome, but persistently reduced proteinuria in just a subgroup. Trial Registration: Registered in the EU Clinical Trials Register with study no. 2013-003826-10.
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- 2019
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7. Long-term kidney and systemic effects of calorie restriction in overweight or obese type 2 diabetic patients (C.Re.S.O. 2 randomized controlled trial)
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Piero Ruggenenti, Monica Cortinovis, Matias Trillini, Aneliya Parvanova, Manuela Abbate, Chiara Satriano, Ferdinando Salvetti, Antonio C. Bossi, Roberto Trevisan, Annalisa Perna, Tobia Peracchi, Nadia Rubis, Olimpia Diadei, Davide Martinetti, Flavio Gaspari, Luigi Fontana, Giuseppe Remuzzi, Ruggenenti, P, Cortinovis, M, Trillini, M, Parvanova, A, Abbate, M, Satriano, C, Salvetti, F, Bossi, A, Trevisan, R, Perna, A, Peracchi, T, Rubis, N, Diadei, O, Martinetti, D, Gaspari, F, Fontana, L, and Remuzzi, G
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Adult ,Male ,Endocrinology, Diabetes and Metabolism ,General Medicine ,Overweight ,Kidney ,Cardiovascular risk ,Nephropathy ,Type 2 diabete ,Endocrinology ,Diabetes Mellitus, Type 2 ,Internal Medicine ,Albuminuria ,Humans ,Diabetic Nephropathies ,Female ,Prospective Studies ,Obesity ,Calorie restriction ,Caloric Restriction ,Glomerular Filtration Rate - Abstract
Aims: In type 2 diabetic patients with obesity, hyperfiltration is a risk factor for accelerated glomerular filtration rate (GFR) decline and is ameliorated by calorie restriction (CR). We assessed whether CR-induced amelioration of hyperfiltration could translate into slower long-term GFR decline in this population. Methods: In this academic, single-center, parallel-group, prospective, randomized, open-label, blinded endpoint trial, consenting >40-year-old patients with type 2 diabetes, BMI ≥27 kg/m2, creatinine
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- 2022
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8. Effect of longacting somatostatin analogue on kidney and cyst growth in autosomal dominant polycystic kidney disease (ALADIN): a randomised, placebo-controlled, multicentre trial
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Annalisa Perna, Fabiola Carrara, Luca Cancian, Erasmo Buongiorno, Luca Antiga, Flavio Gaspari, Bianca Visciano, Anna Caroli, Silvia Prandini, Nadia Rubis, Antonio De Pascalis, Mauro Dugo, Giuseppe Remuzzi, Andrea Remuzzi, Norberto Perico, Roberta Cerutti, Massimo Imbriaco, Antonio Pisani, Piergiorgio Messa, Paolo Brambilla, Piero Ruggenenti, Caroli, A, Perico, N, Perna, A, Antiga, L, Brambilla, P, Pisani, Antonio, Visciano, B, Imbriaco, Massimo, Messa, P, Cerutti, R, Dugo, M, Cancian, L, Buongiorno, E, De Pascalis, A, Gaspari, F, Carrara, F, Rubis, N, Prandini, S, Remuzzi, A, Remuzzi, G, Ruggenenti, P, and for the ALADIN study, Group
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Adult ,Male ,medicine.medical_specialty ,Cholecystitis, Acute ,Autosomal dominant polycystic kidney disease ,Renal function ,Kidney ,Octreotide ,Placebo ,law.invention ,Gastrointestinal Agents ,Randomized controlled trial ,Cholelithiasis ,law ,Internal medicine ,Polycystic kidney disease ,medicine ,Clinical endpoint ,Humans ,Intention-to-treat analysis ,business.industry ,Settore ING-IND/34 - Bioingegneria Industriale ,Organ Size ,General Medicine ,Middle Aged ,Polycystic Kidney, Autosomal Dominant ,medicine.disease ,Magnetic Resonance Imaging ,Surgery ,Treatment Outcome ,Italy ,Disease Progression ,Kidney Failure, Chronic ,Female ,Somatostatin ,business ,Follow-Up Studies ,Kidney disease - Abstract
Summary Background Autosomal dominant polycystic kidney disease slowly progresses to end-stage renal disease and has no effective therapy. A pilot study suggested that the somatostatin analogue octreotide longacting release (LAR) could be nephroprotective in this context. We aimed to assess the effect of 3 years of octreotide-LAR treatment on kidney and cyst growth and renal function decline in participants with this disorder. Methods We did an academic, multicentre, randomised, single-blind, placebo-controlled, parallel-group trial in five hospitals in Italy. Adult (>18 years) patients with estimated glomerular filtration rate (GFR) of 40 mL/min per 1·73 m 2 or higher were randomly assigned (central allocation by phone with a computerised list, 1:1 ratio, stratified by centre, block size four and eight) to 3 year treatment with two 20 mg intramuscular injections of octreotide-LAR (n=40) or 0·9% sodium chloride solution (n=39) every 28 days. Study physicians and nurses were aware of the allocated group; participants and outcome assessors were masked to allocation. The primary endpoint was change in total kidney volume (TKV), measured by MRI, at 1 year and 3 year follow-up. Analyses were by modified intention to treat. This study is registered with ClinicalTrials.gov, NCT00309283. Findings Recruitment was between April 27, 2006, and May 12, 2008. 38 patients in the octreotide-LAR group and 37 patients in the placebo group had evaluable MRI scans at 1 year follow-up, at this timepoint, mean TKV increased significantly less in the octreotide-LAR group (46·2 mL, SE 18·2) compared with the placebo group (143·7 mL, 26·0; p=0·032). 35 patients in each group had evaluable MRI scans at 3 year follow-up, at this timepoint, mean TKV increase in the octreotide-LAR group (220·1 mL, 49·1) was numerically smaller than in the placebo group (454·3 mL, 80·8), but the difference was not significant (p=0·25). 37 (92·5%) participants in the octreotide-LAR group and 32 (82·1%) in the placebo group had at least one adverse event (p=0·16). Participants with serious adverse events were similarly distributed in the two treatment groups. However, four cases of cholelithiasis or acute cholecystitis occurred in the octreotide-LAR group and were probably treatment-related. Interpretation These findings provide the background for large randomised controlled trials to test the protective effect of somatostatin analogues against renal function loss and progression to end-stage kidney disease. Funding Polycystic Kidney Disease Foundation.
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- 2013
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