Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

• Biopsy proven chronic allograft nephropathy(CAN) [ Time Frame: 2 years post transplant ] [ Designated as safety issue: No ]
• Patient and graft survival rates [ Time Frame: End of study (5 years) ] [ Designated as safety issue: No ]

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.

• Drug: Tacrolimus
  IV
  Other Names:

  • Prograf
  • FK506
• Drug: mycophenolate mofetil
  IV
  Other Name: Cellcept
• Drug: Prednisone
  IV

• Experimental: 1
  Steroid rapid 5-day withdrawal
  Interventions:

  • Drug: Tacrolimus
  • Drug: mycophenolate mofetil
  • Drug: Prednisone
• Active Comparator: 2
  Standard steroid maintenance
  Interventions:

  • Drug: Tacrolimus
  • Drug: mycophenolate mofetil
  • Drug: Prednisone

Inclusion Criteria:

• Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
• Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
• Subject is 18 years of age or over at the time of transplant.
• If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

• Recipients of a kidney from a donor 60 years of age or older
• Recipients of donation after cardiac death (DCD) donors
• Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
• Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
• Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20
• Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
• Subjects receiving an allograft with cold ischemia time 24 hours or greater
• Subjects who have received an investigational drug within three months prior to randomization
• Subjects who are breastfeeding
• Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
• Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol