LOCKCYST: Lanreotide as Treatment of Polycystic Livers

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00565097
• Collaborator: Ipsen (Industry)
• Enrollment: 38
• Locations: 2
• Arms: 2
• Patients Per Site: 19

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reduction of total liver volume as determined by CT scan [6 months]

Secondary Outcome Measures

1. Reduction of liver volume and individual cyst volume on CT scan. [6 months]

2. Change of kidney volume and individual cyst volume on CT scan [6 months]

3. Symptom evaluation by (validated) questionnaires [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 88 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Gasthuisberg	Leuven		Belgium
2	Radboud University Medical Center	Nijmegen		Netherlands

Sponsors and Collaborators

• Radboud University Medical Center
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00565097
• Other Study ID Numbers: CMO 2007/010;ABR NL16194.091.0
• First Posted: Nov 29, 2007
• Last Update Posted: Feb 17, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Polycystic Liver Disease; Autosomal Dominant Polycystic Kidney Disease; Liver cyst; Lanreotide
• Additional relevant MeSH terms: Liver Diseases; Hepatomegaly; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Lanreotide

Study Results

No Results Posted as of Feb 17, 2009