Lanreotide In Polycystic Kidney Disease Study (LIPS)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD

Treatments

Drug: Lanreotide

Drug: saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02127437

LIPS-01

Details and patient eligibility

About

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.

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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