Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer
NCT00922129 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL
Last updated 2014-01-14
Summary
The purpose of this study is to evaluate the role and effectiveness of conversion to sirolimus versus CNI reduction in renal transplant patients with prostate cancer.
Conditions
Interventions
- DRUG
-
Sirolimus (Rapamune)
Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months
- DRUG
-
Cyclosporin (Neoral) or Tacrolimus (Prograf)
Cyclosporin: 3-4 mg/kg, BID, PO, 24 months Tacrolimus: 0-.038-0.045 mg/kg, BID, PO, 24 months
Sponsors & Collaborators
-
St. Joseph's Healthcare Hamilton
lead OTHER
Principal Investigators
-
Anil Kapoor, MD · McMaster Institute of Urology, McMaster University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2011-01-31
- Completion
- 2011-01-31
Countries
- Canada
Study Locations
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