Lanreotide as Treatment of Polycystic Livers (LOCKCYST)

This study has been completed.
Sponsor:
Collaborator:
Ipsen
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00565097
First received: November 28, 2007
Last updated: February 16, 2009
Last verified: February 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers

Resource links provided by NLM:


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
Placebo Comparator: 2
Placebo
Drug: Placebo
Experimental: 1
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
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: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00565097     History of Changes
Other Study ID Numbers: CMO 2007/010;ABR NL16194.091.0
Study First Received: November 28, 2007
Last Updated: February 16, 2009
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

Additional relevant MeSH terms:
Liver Diseases
Polycystic Kidney Diseases
Multicystic Dysplastic Kidney
Cysts
Polycystic Kidney, Autosomal Dominant
Hepatomegaly
Digestive System Diseases
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Urogenital Abnormalities
Congenital Abnormalities
Neoplasms
Pathological Conditions, Anatomical
Hypertrophy
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014