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 m2 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 m2. We evaluated the renoprotective effect of octreotide-LAR in ADPKD patients at high risk of ESRD because of later-stage ADPKD. The somatostatin analog octreotide long-acting release (octreotide-LAR) slows renal function deterioration in patients in early stages of the disease. In affected patients, renal function may progressively decline up to end-stage renal disease (ESRD), and approximately 10% of those with ESRD are affected by ADPKD. Sacco Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy.Īutosomal dominant polycystic kidney disease (ADPKD) is the most frequent genetically determined renal disease. 11 Department of Management, Information and Production Engineering, University of Bergamo, Bergamo, Italy. ![]() 10 Radiology Unit, Vittorio Emanuele Policlinico Hospital, Catania, Italy.9 Unit of Nephrology and Dialysis, San Giovanni di Dio Hospital, Agrigento, Italy.8 Department of Radiology, Ca' Foncello Hospital, Treviso, Italy.7 Nephrology and Dialysis Department, Ca' Foncello Hospital, Treviso, Italy.6 Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.5 Chair of Nephrology, Department of Public Health, University of Naples Federico II, Naples, Italy.4 Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy. ![]()
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