Lanreotide In Polycystic Kidney Disease Study (LIPS)

November 15, 2019 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Necker Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glomerular filtration rate (GFR)
Time Frame: month 36
month 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular filtration rate (GFR)
Time Frame: month 18
month 18
Glomerular filtration rate (GFR) decline
Time Frame: month 36
month 36
Safety, tolerance
Time Frame: month 36
month 36
Onset or worsening of hypertension
Time Frame: month 18
month 18
Onset or worsening of hypertension
Time Frame: month 36
month 36
Quality of life
Time Frame: month 0
SF-36, EQ5D
month 0
Quality of life
Time Frame: month 18
SF-36, EQ5D
month 18
Quality of life
Time Frame: month 36
SF-36, EQ5D
month 36
Cystic pain
Time Frame: month 36
month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

IPSEN pharmaceutical company, Boulogne-Billancourt, France

Investigators

  • Principal Investigator: Dominique JOLY, MD, PhD, Necker Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2014

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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