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| Name | Class |
|---|---|
| Ipsen | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Placebo |
|
| 1 | Experimental | Lanreotide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Lanreotide |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of total liver volume as determined by CT scan | 6 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Gasthuisberg | Leuven | Belgium | ||||
| Radboud University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356039 | Derived | St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3. |
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| ID | Term |
|---|---|
| C536330 | Polycystic liver disease |
| D006529 | Hepatomegaly |
| D008107 | Liver Diseases |
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C060347 | lanreotide |
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|
| 6 months |
| Nijmegen |
| Netherlands |
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |