ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Lanreotide In Polycystic kidney disease Study
Previous Study | Return to List | Next Study

Lanreotide In Polycystic Kidney Disease Study (LIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02127437
Recruitment Status : Active, not recruiting
First Posted : April 30, 2014
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
IPSEN pharmaceutical company, Boulogne-Billancourt, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease (ADPKD Drug: Lanreotide Drug: saline Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Lanreotide In Polycystic Kidney Disease Study
Actual Study Start Date : September 19, 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: A - treated group Drug: Lanreotide
120 mg, subcutaneously, once every 4 weeks

Placebo Comparator: B - control group Drug: saline
0,5 ml, subcutaneously, once every 4 weeks




Primary Outcome Measures :
  1. Glomerular filtration rate (GFR) [ Time Frame: month 36 ]

Secondary Outcome Measures :
  1. Glomerular filtration rate (GFR) [ Time Frame: month 18 ]
  2. Glomerular filtration rate (GFR) decline [ Time Frame: month 36 ]
  3. Safety, tolerance [ Time Frame: month 36 ]
  4. Onset or worsening of hypertension [ Time Frame: month 18 ]
  5. Onset or worsening of hypertension [ Time Frame: month 36 ]
  6. Quality of life [ Time Frame: month 0 ]
    SF-36, EQ5D

  7. Quality of life [ Time Frame: month 18 ]
    SF-36, EQ5D

  8. Quality of life [ Time Frame: month 36 ]
    SF-36, EQ5D

  9. Cystic pain [ Time Frame: month 36 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127437


Locations
France
Necker hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
IPSEN pharmaceutical company, Boulogne-Billancourt, France
Investigators
Principal Investigator: Dominique JOLY, MD, PhD Necker hospital

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02127437     History of Changes
Other Study ID Numbers: LIPS-01
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Autosomal dominant polycystic kidney disease,
Glomerular filtration rate,
Somatostatin,
lanreotide

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Genetic Diseases, Inborn
Lanreotide
Angiopeptin
Abnormalities, Multiple
Congenital Abnormalities
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs