Requests can be directed to Francesco Peraro ( of the Laboratory of Biostatistics of the Department of Renal Medicine of the Istituto di Ricerche Farmacologiche Mario Negri IRCCS. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.ĭata Availability: ALADIN 2 study data may be made available to interested researchers upon request. Received: NovemAccepted: MaPublished: April 5, 2019Ĭopyright: © 2019 Perico et al. Taal, Royal Derby Hospital, UNITED KINGDOM PLoS Med 16(4):Īcademic Editor: Maarten W. (2019) Octreotide-LAR in later-stage autosomal dominant polycystic kidney disease (ALADIN 2): A randomized, double-blind, placebo-controlled, multicenter trial. The main study limitation was the small sample size.Ĭitation: Perico N, Ruggenenti P, Perna A, Caroli A, Trillini M, Sironi S, et al. Three patients on placebo had a serious renal cyst rupture/infection and 1 patient had a serious urinary tract infection/obstruction, versus 1 patient on octreotide-LAR with a serious renal cyst infection. Among 63 patients with chronic kidney disease (CKD) stage 4, 3 on octreotide-LAR and 8 on placebo progressed to ESRD (adjusted HR : 0.121, p = 0.036). One composite endpoint was prevented for every 4 treated patients. Over a median (IQR) 36 (24 to 37) months of follow-up, 9 patients on octreotide-LAR and 21 patients on placebo progressed to a doubling of serum creatinine or ESRD (composite endpoint) (hazard ratio adjusted for age, sex, baseline serum creatinine, and baseline TKV: 0.307, p = 0.009). TKV analyses were adjusted for age, sex, and baseline TKV. Reduction in the median (95% CI) rate of GFR decline (0.56 ml/min/1.73 m 2 per year) was not significant ( p = 0.295). Baseline characteristics were similar between groups. Patients were recruited from 4 Italian nephrology units between October 11, 2011, and March 20, 2014, and followed up to April 14, 2017. Analyses were by modified intention-to-treat. Co-primary short- and long-term outcomes were 1-year total kidney volume (TKV) (computed tomography scan) growth and 3-year GFR (iohexol plasma clearance) decline. Central randomization was 1:1 using a computerized list stratified by center and presence or absence of diabetes or proteinuria. Participants were randomized to receive 2 intramuscular injections of 20 mg octreotide-LAR ( n = 51) or 0.9% sodium chloride solution (placebo n = 49) every 28 days for 3 years. We did an internally funded, parallel-group, double-blind, placebo-controlled phase III trial to assess octreotide-LAR in adults with ADPKD with glomerular filtration rate (GFR) 15–40 ml/min/1.73 m 2.
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