Effect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADI

Phase 1

• Conditions: Autosomal Dominant Polycystic Kidney Disease ADPKD; MedDRA version: 6.1 Level: SOC Classification code 10038359

• Registration Number: EUCTR2005-005552-41-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-06
• Study Completion: 2012-01-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 66

Inclusion Criteria

- Age 18 years - Clinical and ultrasound diagnosis of ADPKD - GFR 40 ml/min/1-73 m2 estimated by the 4 variable MDRD equation - Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
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

Exclusion Criteria

- Diabetes; - Overt proteinuria urinary protein excretion rate 1g/24 hours or abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease; - Urinary tract lithiasis, infection or obstruction; - Cancer; - Psychiatric disorders and 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