DRUG
Lanreotide
120 mg, subcutaneously, once every 4 weeks
Lanreotide In Polycystic Kidney Disease Study
Status
Completed
Phase
Phase 3
Enrollment
159
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
saline
0,5 ml, subcutaneously, once every 4 weeks
Timeline
From registration to results.
First posted
Apr 30, 2014
Study start
Sep 19, 2014
Primary completion
Jul 31, 2019
Study completion
Jul 31, 2019
Results posted
Not reported
Registry updated
Apr 8, 2026
Outcomes
What the study measures.
Primary outcomes
Glomerular filtration rate (GFR)
Time frame · month 36
Secondary outcomes
Glomerular filtration rate (GFR)
Time frame · month 18
Glomerular filtration rate (GFR) decline
Time frame · month 36
Safety, tolerance
Time frame · month 36
Onset or worsening of hypertension
Time frame · month 18
Onset or worsening of hypertension
Time frame · month 36
Quality of life
Time frame · month 0
SF-36, EQ5D
Quality of life
Time frame · month 18
SF-36, EQ5D
Quality of life
Time frame · month 36
SF-36, EQ5D
Cystic pain
Time frame · month 36
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
Necker hospital
Paris, France
Publications
Results and literature.
PMID 42320793 ↗Joly D, Ursino M, Bienaime F, El Karoui K, Karras A, Thervet E, Boffa JJ, Galichon P, Luque Y, Michel PA, Cartery C, Vrtovsnik F, Daugas E, Peraldi MN, Colas S, Semeraro M, Treluyer JM, Meyzer C, Hummel A, Fouchard M, Nguyen-Khoa T, Knebelmann B, Alberti C. A three-year randomized, double-blind, placebo-controlled study of lanreotide in stage 2/3 autosomal dominant polycystic kidney disease. Kidney Int. 2026 Jun 19:S0085-2538(26)00498-9. doi: 10.1016/j.kint.2026.05.018. Online ahead of print.PMID 39356039 ↗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.
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