NCT02127437

Lanreotide In Polycystic Kidney Disease Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autosomal Dominant Polycystic Kidney Disease (ADPKD

Interventions

Type	Name	Description
DRUG	Lanreotide	120 mg, subcutaneously, once every 4 weeks
DRUG	saline	0,5 ml, subcutaneously, once every 4 weeks

Timeline

• Start date: 2014-09-19
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2014-04-30
• Last updated: 2026-04-08

Locations

1 site across 1 country: France