Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE) - Full Text View

Sponsor:	Radboud University
Collaborator:	Ipsen
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT01354405

Purpose

The aim of this study is to determine the effect of Lanreotide on polycystic liver and kidneys in patients with autosomal dominant polycystic kidney disease.

Condition	Intervention
Polycystic Liver Disease	Drug: Lanreotide

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases

Drug Information available for: Lanreotide Lanreotide acetate

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

Liver volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry

Secondary Outcome Measures:

Kidney volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry
Glomerular filtration rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement
Urinary tubular damage markers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in urinary tubular damage markers between baseline and 24 weeks
Symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire
Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in blood pressure between baseline and 24 weeks
quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire
Adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
All adverse events that occur during 24 weeks of treatment

Biospecimen Retention: Samples With DNA

Blood samples

Estimated Enrollment:	43
Study Start Date:	May 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Lanreotide	Drug: Lanreotide 120 mg every 28 days intramuscular Other Name: Somatuline

Detailed Description:

The aim of this single center observational study is to assess the effect of lanreotide on polycystic liver and kidney. This is achieved by assessing total liver and kidney volume, and several urinary markers that could predict kidney damage or kidney dysfunction, such as GFR, blood pressure, and urinary tubular damage markers and serum biomarker FGF23.

The investigators aim to include 43 patients affected by a polycystic liver due to ADPKD. The duration of the trial will be 28 weeks. The treatment will be 24 weeks and the first screening visit will take place four weeks before start of treatment. Eligible patients will be invited to participate.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

ADPKD patients in Radboud University Hospital

Criteria

Inclusion Criteria:

Patients with ADPKD with polycystic liver (> 20 liver cysts)
Renal function MDRD >40 ml/hr
Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements

Exclusion Criteria:

Kidney transplantation
Renal failure requiring hemodialysis
Use of oral contraceptives or estrogen suppletion
Women who are pregnant or breastfeeding
History of cardiac/pulmonary disease; symptomatic gallstones, pancreatitis, etc
Intervention (aspiration or surgical intervention) within three months from baseline
Treatment with somatostatin analogues within three months from baseline
Mental illness that interferes with the patient ability to comply with the protocol
Drug or alcohol abuse within one year from baseline
Abnormal liver function tests, as determined by blood test (except isolated elevated GGT and AP, which occurs frequently in PLD)
Clinical diagnosis of pancreatitis
Diagnosis of diabetes mellitus, as determined by blood test and medical history
Use of drugs that can interact with lanreotide, such as cyclosporin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354405

Contacts

Contact: Tom JG Gevers, MD, Msc	+3124 3614760	T.Gevers@mdl.umcn.nl
Contact: Joost PH Drenth, MD, PhD	+3124 3614760	joostphdrenth@cs.com

Locations

Netherlands
Radboud University Hospital	Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Tom JG Gevers, MD, Msc +3124 3614760 t.gevers@mdl.umcn.nl
Principal Investigator: Joost PH Drenth, MD, PhD

Sponsors and Collaborators

Radboud University

Ipsen

Investigators

Principal Investigator:

Joost PH Drenth, MD, PhD

Radboud University Hospital

More Information

Additional Information:

related info This link exits the ClinicalTrials.gov site

Publications:

van Keimpema L, Nevens F, Vanslembrouck R, van Oijen MG, Hoffmann AL, Dekker HM, de Man RA, Drenth JP. Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2009 Nov;137(5):1661-8.e1-2. Epub 2009 Jul 29.

Responsible Party:	Joost PH Drenth, MD, PhD, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier:	NCT01354405 History of Changes
Other Study ID Numbers:	PCLD 10-03
Study First Received:	May 13, 2011
Last Updated:	May 13, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:

Polycystic Kidney Diseases
Liver Diseases
Polycystic Kidney, Autosomal Dominant
Cysts
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Digestive System Diseases

Neoplasms
Pathological Conditions, Anatomical
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2012