Lanreotide In Polycystic Kidney Disease Study (LIPS)
Primary Purpose
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Lanreotide
saline
Sponsored by
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease (ADPKD focused on measuring Autosomal dominant polycystic kidney disease,, Glomerular filtration rate,, Somatostatin,, lanreotide
Eligibility Criteria
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
Sites / Locations
- Necker hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A - treated group
B - control group
Arm Description
Outcomes
Primary Outcome Measures
Glomerular filtration rate (GFR)
Secondary Outcome Measures
Glomerular filtration rate (GFR)
Glomerular filtration rate (GFR) decline
Safety, tolerance
Onset or worsening of hypertension
Onset or worsening of hypertension
Quality of life
SF-36, EQ5D
Quality of life
SF-36, EQ5D
Quality of life
SF-36, EQ5D
Cystic pain
Full Information
NCT ID
NCT02127437
First Posted
April 2, 2014
Last Updated
November 15, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
IPSEN pharmaceutical company, Boulogne-Billancourt, France
1. Study Identification
Unique Protocol Identification Number
NCT02127437
Brief Title
Lanreotide In Polycystic Kidney Disease Study
Acronym
LIPS
Official Title
Lanreotide In Polycystic Kidney Disease Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 19, 2014 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
IPSEN pharmaceutical company, Boulogne-Billancourt, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Keywords
Autosomal dominant polycystic kidney disease,, Glomerular filtration rate,, Somatostatin,, lanreotide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A - treated group
Arm Type
Experimental
Arm Title
B - control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lanreotide
Intervention Description
120 mg, subcutaneously, once every 4 weeks
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
0,5 ml, subcutaneously, once every 4 weeks
Primary Outcome Measure Information:
Title
Glomerular filtration rate (GFR)
Time Frame
month 36
Secondary Outcome Measure Information:
Title
Glomerular filtration rate (GFR)
Time Frame
month 18
Title
Glomerular filtration rate (GFR) decline
Time Frame
month 36
Title
Safety, tolerance
Time Frame
month 36
Title
Onset or worsening of hypertension
Time Frame
month 18
Title
Onset or worsening of hypertension
Time Frame
month 36
Title
Quality of life
Description
SF-36, EQ5D
Time Frame
month 0
Title
Quality of life
Description
SF-36, EQ5D
Time Frame
month 18
Title
Quality of life
Description
SF-36, EQ5D
Time Frame
month 36
Title
Cystic pain
Time Frame
month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique JOLY, MD, PhD
Organizational Affiliation
Necker hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necker hospital
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
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Lanreotide In Polycystic Kidney Disease Study
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