LIPS: Lanreotide In Polycystic Kidney Disease Study

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02127437

Collaborator

IPSEN pharmaceutical company, Boulogne-Billancourt, France (Other)

159

Enrollment

Location

Arms

58.3

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autosomal Dominant Polycystic Kidney Disease (ADPKD	Drug: Lanreotide Drug: saline	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

159 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Lanreotide In Polycystic Kidney Disease Study

Actual Study Start Date :

Sep 19, 2014

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A - treated group	Drug: Lanreotide 120 mg, subcutaneously, once every 4 weeks
Placebo Comparator: B - control group	Drug: saline 0,5 ml, subcutaneously, once every 4 weeks

Arm

Intervention/Treatment

Experimental: A - treated group

Drug: Lanreotide

120 mg, subcutaneously, once every 4 weeks

Placebo Comparator: B - control group

Drug: saline

0,5 ml, subcutaneously, once every 4 weeks

Outcome Measures

Primary Outcome Measures

Glomerular filtration rate (GFR) [month 36]

Secondary Outcome Measures

Glomerular filtration rate (GFR) [month 18]
Glomerular filtration rate (GFR) decline [month 36]
Safety, tolerance [month 36]
Onset or worsening of hypertension [month 18]
Onset or worsening of hypertension [month 36]
Quality of life [month 0]
SF-36, EQ5D
Quality of life [month 18]
SF-36, EQ5D
Quality of life [month 36]
SF-36, EQ5D
Cystic pain [month 36]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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