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Lanreotide In Polycystic Kidney Disease Study (LIPS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
IPSEN pharmaceutical company, Boulogne-Billancourt, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02127437
First received: April 2, 2014
Last updated: April 28, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Drug: Lanreotide
Drug: saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Lanreotide In Polycystic Kidney Disease Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Glomerular filtration rate (GFR) [ Time Frame: month 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glomerular filtration rate (GFR) [ Time Frame: month 18 ] [ Designated as safety issue: No ]
  • Glomerular filtration rate (GFR) decline [ Time Frame: month 36 ] [ Designated as safety issue: No ]
  • Safety, tolerance [ Time Frame: month 36 ] [ Designated as safety issue: Yes ]
  • Onset or worsening of hypertension [ Time Frame: month 18 ] [ Designated as safety issue: No ]
  • Onset or worsening of hypertension [ Time Frame: month 36 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: month 0 ] [ Designated as safety issue: No ]
    SF-36, EQ5D

  • Quality of life [ Time Frame: month 18 ] [ Designated as safety issue: No ]
    SF-36, EQ5D

  • Quality of life [ Time Frame: month 36 ] [ Designated as safety issue: No ]
    SF-36, EQ5D

  • Cystic pain [ Time Frame: month 36 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: April 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • previous malignant disease
  • cholelithiasis
  • uncontrolled hypertension (BP>160/100 mmHg)
  • cardiac failure
  • liver failure
  • psychiatric illness
  • pregnancy, lactation, lack of contraception
  • use of somatostatin analogs during the last 6 months
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02127437

Contacts
Contact: Dominique JOLY, MD PhD 1 44 49 54 15 ext +33 dominique.joly@nck.aphp.fr
Contact: laurence lecomte, PhD 1 71 19 64 94 ext +33 laurence.lecomte@nck.aphp.fr

Locations
France
Necker hospital Not yet recruiting
Paris, France, 75015
Contact: dominique Joly, MD PhD    1 44 49 54 15 ext +33    dominique.joly@nck.aphp.fr   
Contact: laurence Lecomte, PhD    1 71 19 64 94 ext +33    laurence.lecomte@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
IPSEN pharmaceutical company, Boulogne-Billancourt, France
Investigators
Principal Investigator: Dominique JOLY, MD, PhD Necker hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02127437     History of Changes
Other Study ID Numbers: LIPS-01
Study First Received: April 2, 2014
Last Updated: April 28, 2014
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Congenital Abnormalities
Kidney Diseases, Cystic
Urogenital Abnormalities
Urologic Diseases
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014