Status:
WITHDRAWN
Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Conditions:
Prostate Cancer
Eligibility:
MALE
18-50 years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
This study is designed to support the optimal use of mTOR-inhibitor by providing data for the safe and effectiveness use with sirolimus. This study will take into account effectiveness aspects such as...
Eligibility Criteria
Inclusion
- Male patients ≤ 50 years in their post renal transplant follow-up;
- Biopsy confirmed prostate cancer;
- Stable renal function with GFR ≥ 40 mL/min.
Exclusion
- Patients with metastatic disease;
- Uncontrolled hyperlipidemia;
- Proteinuria \> 500 mg/day;
- Biopsy evidence of acute rejection within the past 3 months;
- Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication;
- Patients with mental illness;
- Inability to cooperate or communicate with the investigator or unable to complete self administered questionnaires.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00922129
Start Date
September 1 2009
End Date
January 1 2011
Last Update
January 14 2014
Active Locations (1)
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1
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6