Lanreotide In Polycystic Kidney Disease Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02127437

Acronym

LIPS

Enrollment

159

Registered

2014-04-30

Start date

2014-09-19

Completion date

2019-07-31

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD

Keywords

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

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.

Interventions

DRUGLanreotide

120 mg, subcutaneously, once every 4 weeks

DRUGsaline

0,5 ml, subcutaneously, once every 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Glomerular filtration rate (GFR)	month 36

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORDominique JOLY, MD, PhD

Necker hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026