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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
April 2, 2014
Last Updated
November 15, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
IPSEN pharmaceutical company, Boulogne-Billancourt, France
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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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