Clinical Trial: Lanreotide In Polycystic Kidney Disease Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Lanreotide In Polycystic Kidney Disease Study
Brief Summary:
LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014.
An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.
Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Glomerular filtration rate (GFR) [ Time Frame: month 36 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Glomerular filtration rate (GFR) [ Time Frame: month 18 ]
- Glomerular filtration rate (GFR) decline [ Time Frame: month 36 ]
- Safety, tolerance [ Time Frame: month 36 ]
- Onset or worsening of hypertension [ Time Frame: month 18 ]
- Onset or worsening of hypertension [ Time Frame: month 36 ]
- Quality of life [ Time Frame: month 0 ]SF-36, EQ5D
- Quality of life [ Time Frame: month 18 ]SF-36, EQ5D
- Quality of life [ Time Frame: month 36 ]SF-36, EQ5D
- Cystic pain [ Time Frame: month 36 ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: April 2, 2014
Date Started: September 2014
Date Completion: April 2019
Last Updated: August 25, 2016
Last Verified: August 2016
