Lanreotide In Polycystic Kidney Disease Study

Phase 3

Completed

• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD
• Interventions: Drug: Lanreotide; Drug: saline

• Registration Number: NCT02127437
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Study Start: 2014-09-19
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - treated group	Lanreotide	-
B - control group	saline	-

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate (GFR)	month 36

Secondary Outcome Measures

Name	Time	Method
Glomerular filtration rate (GFR)	month 18
Quality of life	month 36	SF-36, EQ5D
Glomerular filtration rate (GFR) decline	month 36
Safety, tolerance	month 36
Onset or worsening of hypertension	month 36
Cystic pain	month 36

Trial Locations

Locations (1)

Necker hospital; 🇫🇷 Paris, France