EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN II

Phase 1

• Conditions: Polycystic Kidney; MedDRA version: 12.1Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominant

• Registration Number: EUCTR2009-012376-27-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: 2009-11-30
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Age > 18 years Clinical and ultrasound diagnosis of ADPKD Estimated GFR between 40-15 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:
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 Mellitus Other primary or secondary renal diseases. Proteinuria excretion rate >1g/24 hours or abnormal urinalysis suggestive of concomitant glomerular disease Urinary tract lithiasis or obstruction Current urinary tract infection 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