Lanreotide as Treatment of Polycystic Livers - Full Text View

Sponsors and Collaborators:	Radboud University Ipsen
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00565097

Purpose

To assess the efficacy of lanreotide in controling total liver volume in patients with polycystic livers this study will be performed. A minimum of 38 patients will be recruited and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other disease states and found to be safe and non-toxic.

Condition	Intervention	Phase
Polycystic Liver Disease Hepatomegaly Liver Diseases Polycystic Kidney, Autosomal Dominant	Drug: Placebo Drug: Lanreotide	Phase II Phase III

Genetics Home Reference related topics: polycystic kidney disease

MedlinePlus related topics: CT Scans Liver Diseases Nuclear Scans

Drug Information available for: Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers

Further study details as provided by Radboud University:

Primary Outcome Measures:

Reduction of total liver volume as determined by CT scan [ Time Frame: 6 months ]

Secondary Outcome Measures:

Reduction of liver volume and individual cyst volume on CT scan. [ Time Frame: 6 months ]
Change of kidney volume and individual cyst volume on CT scan [ Time Frame: 6 months ]
Symptom evaluation by (validated) questionnaires [ Time Frame: 6 months ]

Estimated Enrollment:	38
Study Start Date:	October 2007

Arms	Assigned Interventions
2: Placebo Comparator Placebo	Drug: Placebo
1: Experimental Lanreotide	Drug: Lanreotide

Eligibility

Ages Eligible for Study:	18 Years to 88 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 yrs-of age
Multiple cysts > 20
Cooperating patient
Is willing and able to comply with the study drug regimen and all other study requirements
Willingness to give written informed consent

Exclusion Criteria:

Use of oral anticonceptives or estrogen suppletion
Females who are pregnant or breast-feeding
History or other evidence of chronic pulmonary disease associated with functional limitation
History of severe cardiac disease
History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Symptomatic gallstones
Renal failure requiring hemodialysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565097

Locations

Belgium
University Hospital Gasthuisberg
Leuven, Belgium
Netherlands
Radboud University Medical Center
Nijmegen, Netherlands

Sponsors and Collaborators

Radboud University

Ipsen

Investigators

Principal Investigator:	Joost PH Drenth, MD, PhD	Radboud University Medical Center Nijmegen
Principal Investigator:	Loes van Keimpema, MSc	Radboud University Medical Center Nijmegen
Principal Investigator:	Frederik Nevens, MD, PhD	University Hospital Gasthuisberg, University of Leuven

More Information

Additional Information:

The website that informs on polycystic liver disease This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CMO 2007/010;ABR NL16194.091.0
Study First Received:	November 28, 2007
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00565097 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

Polycystic Liver Disease
Autosomal Dominant Polycystic Kidney Disease
Liver cyst
Lanreotide

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Liver Diseases
Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Polycystic Liver Disease
Polycystic Kidney Diseases
Angiopeptin
Cardiovascular Agents

Cysts
Lanreotide
Hypertrophy
Digestive System Diseases
Urologic Diseases
Kidney Diseases
Hepatomegaly
Autosomal Dominant Polycystic Kidney Disease

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Liver Diseases
Polycystic Kidney, Autosomal Dominant
Antineoplastic Agents
Kidney Diseases, Cystic
Polycystic Kidney Diseases
Angiopeptin
Cardiovascular Agents

Pharmacologic Actions
Hypertrophy
Lanreotide
Digestive System Diseases
Urologic Diseases
Therapeutic Uses
Kidney Diseases
Hepatomegaly

ClinicalTrials.gov processed this record on May 07, 2009