Skip to main content
OpenTrials
Completed

NCT Number: NCT02127437

Lanreotide In Polycystic Kidney Disease Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Necker hospital

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanreotide

Drug

120 mg, subcutaneously, once every 4 weeks

Saline

Drug

0,5 ml, subcutaneously, once every 4 weeks

Primary outcomes

  1. Glomerular filtration rate (GFR)

    Time frame: month 36

Secondary outcomes

  1. Glomerular filtration rate (GFR)

    Time frame: month 18

  2. Glomerular filtration rate (GFR) decline

    Time frame: month 36

  3. Safety, tolerance

    Time frame: month 36

  4. Onset or worsening of hypertension

    Time frame: month 18

  5. Onset or worsening of hypertension

    Time frame: month 36

  6. Quality of life

    Time frame: month 0

    SF-36, EQ5D

  7. Quality of life

    Time frame: month 18

    SF-36, EQ5D

  8. Quality of life

    Time frame: month 36

    SF-36, EQ5D

  9. Cystic pain

    Time frame: month 36

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • IPSEN pharmaceutical company, Boulogne-Billancourt, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: LIPS

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2014
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.