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
- Conditions
- Autosomal Dominant Polycystic Kidney DiseaseMedDRA version: 14.1 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant System Organ Class: 10010331 - Congenital, familial and genetic disorders
- Registration Number
- EUCTR2011-000138-12-IT
- Lead Sponsor
- IST. DI RICERCHE FARMACOLOG. M. NEGRI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
- 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method