Lanreotide In Polycystic Kidney Disease Study

Study Overview
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Brief Summary
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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.

Official Title
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Lanreotide In Polycystic Kidney Disease Study

Conditions
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Autosomal Dominant Polycystic Kidney Disease (ADPKD

Intervention / Treatment
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* Drug: Lanreotide
* Drug: saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - treated group<br> | Drug: Lanreotide<br>* 120 mg, subcutaneously, once every 4 weeks<br>|
| Placebo Comparator: B - control group<br> | Drug: saline<br>* 0,5 ml, subcutaneously, once every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate (GFR) |  | month 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Quality of life | SF-36, EQ5D | month 0 | 
| Quality of life | SF-36, EQ5D | month 18 | 
| Quality of life | SF-36, EQ5D | month 36 | 
| Cystic pain |  | month 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autosomal dominant polycystic kidney disease,, Glomerular filtration rate,, Somatostatin,, lanreotide