NCT02127437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

September 19, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

April 8, 2026

Status Verified

November 1, 2019

Enrollment Period

4.9 years

First QC Date

April 2, 2014

Last Update Submit

April 2, 2026

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD

Keywords

Autosomal dominant polycystic kidney disease,Glomerular filtration rate,Somatostatin,lanreotide

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate (GFR)

    month 36

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

A - treated group

EXPERIMENTAL
Drug: Lanreotide

B - control group

PLACEBO COMPARATOR
Drug: saline

Interventions

LanreotideDRUG

120 mg, subcutaneously, once every 4 weeks

A - treated group
salineDRUG

0,5 ml, subcutaneously, once every 4 weeks

B - control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker hospital

Paris, 75015, France

Location

Related Publications (1)

  • St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

    PMID: 39356039DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

lanreotideSodium Chloride

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Dominique JOLY, MD, PhD

    Necker hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 30, 2014

Study Start

September 19, 2014

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

April 8, 2026

Record last verified: 2019-11

Locations

FR(1)