Lanreotide In Polycystic Kidney Disease Study

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Brief Title

Lanreotide In Polycystic Kidney Disease Study

Official Title

Lanreotide In Polycystic Kidney Disease Study

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Glomerular filtration rate (GFR)

Secondary Outcome

 Glomerular filtration rate (GFR)

Condition

Autosomal Dominant Polycystic Kidney Disease (ADPKD

Intervention

Lanreotide

Study Arms / Comparison Groups

 A - treated group
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

159

Start Date

September 19, 2014

Completion Date

July 31, 2019

Primary Completion Date

July 31, 2019

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Dominique JOLY, MD, PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02127437

Organization ID

LIPS-01


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

 IPSEN pharmaceutical company, Boulogne-Billancourt, France

Study Sponsor

Dominique JOLY, MD, PhD, Principal Investigator, Necker hospital


Verification Date

November 2019