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Sponsored by: |
University of Zurich |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00346918 |
The aim of our study is to investigate whether Rapamune used at a low dose (2 mg/d) retards cyst growth and slows renal functional deterioration in patients with ADPKD.
Condition | Intervention | Phase |
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Autosomal Dominant Polycystic Kidney Disease (ADPKD) |
Drug: Sirolimus Other: Standard |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Sirolimus (Rapamune®) for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD): a Randomized Controlled Study. |
Estimated Enrollment: | 100 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Treatment of hypertension, cyst infections and flank pain
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Other: Standard
Standard
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2: Active Comparator
Sirolimus plus Standard Treatment
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Drug: Sirolimus
Standard plus Sirolimus
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Currently there is no treatment for ADPKD other than supportive care and blood pressure control. Usually dialytic treatment or renal transplantation becomes necessary when the disease has progressed to end-stage renal failure.We and others could demonstrate that rapamycin, a classical mTOR inhibitor, retards cyst growth and preserves renal function in a rodent model of ADPKD. The aim of our study is to investigate whether Rapamune (2 mg/d) retards cyst growth and slows renal functional deterioration in patients with ADPKD. We anticipate that we can slow disease progression and delay the need for chronic renal replacement therapy by the inhibition of mTOR with Rapamune. This is a 24-month prospective, controlled, open label study with 2 parallel groups in patients with ADPKD. Patients will be randomized at a 1:1 ratio to one of the 2 treatment arms. Primary endpoint is percentage change of renal volume measured by high resolution magnetic resolution imaging.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University Hospital Zurich ( Andreas L. Serra, MD ) |
Study ID Numbers: | EK-1246 |
Study First Received: | June 22, 2006 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00346918 |
Health Authority: | Switzerland: Swissmedic |
ADPKD autosomal dominant polycystic kidney disease Sirolimus volumetry |
Sirolimus Urologic Diseases Clotrimazole Polycystic Kidney, Autosomal Dominant Miconazole |
Kidney Diseases, Cystic Tioconazole Polycystic Kidney Diseases Kidney Diseases |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |