Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND

Phase 1

• Conditions: Autosomal-Dominant Polycystic Kidney Disease ADPKD; MedDRA version: 9.1 Level: LLT Classification code 10010428 Term: Congenital cystic kidney disease

• Registration Number: EUCTR2006-003427-37-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: 2006-12-27
• Study Completion: 2009-07-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 16

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