Lanreotide In Polycystic Kidney Disease Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-19

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Autosomal Dominant Polycystic Kidney Disease (ADPKD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A - treated group

Group Type EXPERIMENTAL

Lanreotide

Intervention Type DRUG

120 mg, subcutaneously, once every 4 weeks

B - control group

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

0,5 ml, subcutaneously, once every 4 weeks

Interventions

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Lanreotide

120 mg, subcutaneously, once every 4 weeks

Intervention Type DRUG

saline

0,5 ml, subcutaneously, once every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No