Lanreotide in Polycystic Kidney Disease Study (LIPS)
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.
- Drug: Lanreotide
- Drug: Saline
18 and older
Necker Hospital - Paris, France
- ADPKD (clinical, familial, imaging grounds)
- Measured GFR: 30 to 89 ml/mn/1.73m2
- Affiliated with health insurance
- Written informed consent
- Iohexol /iodine allergy
- Diabetes mellitus
- Other associated nephropathy suspected
- Previous malignant disease
- Uncontrolled hypertension (BP>160/100 mmHg)
- Cardiac failurev
- Liver failure
- Psychiatric illness
- Pregnancy, lactation, lack of contraception
- Use of somatostatin analogs during the last 6 months
Dominique Joly, M.D., Ph.D.
1 44 49 54 15 ext. +33
Laurence Lecomte, Ph.D.
1 71 19 64 94 ext. +33