Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer

This study has been withdrawn prior to enrollment.
(Study did not start up as planned.)
Sponsor:
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00922129
First received: June 16, 2009
Last updated: January 13, 2014
Last verified: January 2014

June 16, 2009
January 13, 2014
September 2009
January 2011   (final data collection date for primary outcome measure)
Malignancy-free survival [ Time Frame: Months 3, 9, 15, 21 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00922129 on ClinicalTrials.gov Archive Site
  • Renal function as measured by serum creatinine and calculated creatinine clearance (using the formula of Cockcroft-Gault) [ Time Frame: Weeks 1, 3, 6, Months 3, 6, 9, 12, 15, 18, 21 and 24 ] [ Designated as safety issue: Yes ]
  • Testosterone levels [ Time Frame: Months 6, 12, 18 and 24 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Months 6, 12, 18 and 24 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer
A Prospective Randomized Pilot Study Examining the Role and Effectiveness of Conversion to Sirolimus Versus CNI Reduction in Renal Transplant Patients With Prostate Cancer

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.

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 malignancy-free survival cancer by reducing the overall exposure to calcineurin inhibitor.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Sirolimus (Rapamune)
    Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months
    Other Name: RAPAMUNE
  • 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

    Other Names:
    • Cyclosporin: NEORAL
    • Tacrolimus: PROGRAF
  • Experimental: Conversion to sirolimus
    Intervention: Drug: Sirolimus (Rapamune)
  • Active Comparator: Calcineurim inhibitor reduction
    Intervention: Drug: Cyclosporin (Neoral) or Tacrolimus (Prograf)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male patients ≤ 50 years in their post renal transplant follow-up;
  • Biopsy confirmed prostate cancer;
  • Stable renal function with GFR ≥ 40 mL/min.

Exclusion Criteria:

  • 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.
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00922129
IIS-002-09
No
Dr Anil Kapoor, McMaster Institute of Urology, McMaster University
St. Joseph's Healthcare Hamilton
Not Provided
Principal Investigator: Anil Kapoor, MD McMaster Institute of Urology, McMaster University
St. Joseph's Healthcare Hamilton
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP