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Lanreotide as Treatment of Polycystic Livers (LOCKCYST)

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ClinicalTrials.gov Identifier: NCT00565097
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : February 17, 2009
Information provided by:
Radboud University

Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Liver Disease Hepatomegaly Liver Diseases Polycystic Kidney, Autosomal Dominant Drug: Placebo Drug: Lanreotide Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers
Study Start Date : October 2007

Arm Intervention/treatment
Placebo Comparator: 2
Drug: Placebo
Experimental: 1
Drug: Lanreotide

Primary Outcome Measures :
  1. Reduction of total liver volume as determined by CT scan [ Time Frame: 6 months ]

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

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00565097

University Hospital Gasthuisberg
Leuven, Belgium
Radboud University Medical Center
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
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

ClinicalTrials.gov Identifier: NCT00565097     History of Changes
Other Study ID Numbers: CMO 2007/010;ABR NL16194.091.0
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: February 2009

Keywords provided by Radboud University:
Polycystic Liver Disease
Autosomal Dominant Polycystic Kidney Disease
Liver cyst

Additional relevant MeSH terms:
Liver Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Digestive System Diseases
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Pathological Conditions, Anatomical
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs