Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant, Polycystic Liver Disease
Conditions
Keywords
Polycystic Liver Disease, Autosomal Dominant Polycystic Kidney Disease, Liver cyst, Lanreotide
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.
Interventions
DRUGPlacebo
DRUGLanreotide
Sponsors
Ipsen
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of total liver volume as determined by CT scan | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of liver volume and individual cyst volume on CT scan. | 6 months |
| Change of kidney volume and individual cyst volume on CT scan | 6 months |
| Symptom evaluation by (validated) questionnaires | 6 months |
Countries
Belgium, Netherlands
Outcome results
None listed