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COMPLETED
NCT02127437
PHASE3

Lanreotide In Polycystic Kidney Disease Study

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

159

Start Date

2014-09-19

Completion Date

2019-07-31

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Lanreotide

120 mg, subcutaneously, once every 4 weeks

DRUG

saline

0,5 ml, subcutaneously, once every 4 weeks

Locations (1)

Necker hospital

Paris, France