Lanreotide In Polycystic Kidney Disease Study

• Status: Completed
• Trial end date: 2019-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: IPSEN pharmaceutical company, Boulogne-Billancourt, France
• Treatments: Angiopeptin; Lanreotide; Somatostatin

Criteria

Inclusion Criteria:

• autosomal dominant polycystic kidney disease (clinical, familial, imaging grounds)

• measured GFR : 30 to 89 ml/mn/1.73m2

• age > 18

• affiliated with health insurance

• written informed consent

Exclusion Criteria:

• iohexol /iodine allergy

• diabetes mellitus

• other associated nephropathy suspected

• evolutive or recent malignant disease ( in the previous 5 years)

• cholelithiasis

• uncontrolled hypertension (BP>160/100 mmHg)

• cardiac failure of grade III or IV according to the NYHA (New York Heart Association) classification

• liver failure

• psychiatric illness

• pregnancy, lactation, lack of contraception

• use of somatostatin analogs during the last 6 months