A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 100 人开始时间: 2011年12月28日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- Age > 18 years - Clinical and ultrasound diagnosis of ADPKD - Estimated GFR between 15 and 40 ml/min/1.73m2 (by the MDRD 4 variable equation) - Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- 24-h Urinary protein excretion rate >3g (suggestive of a concomitant glomerular disease that could benefit of specific therapy) - Symptomatic urinary tract lithiasis or obstruction - Uncontrolled diabetes mellitus (HbA1c >8%) or hypertension (systolic/diastolic BP >180/110 mmHg) - Current urinary tract infection - Symptomatic biliary tract lithiasis - Active cancer - Psychiatric disorders or any condition that might prevent full comprehension of the purposes and risks of the study - Pregnancy, lactation or child bearing potential and ineffective contraception (estrogen therapy in post menopausal women should not be stopped)

发起方

IST. DI RICERCHE FARMACOLOG. M. NEGRI