Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: mycophenolate mofetil
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Steroid rapid 5-day withdrawal | Drug: Tacrolimus<br>* IV<br>* Other names: FK506;Drug: mycophenolate mofetil<br>* IV<br>* Other names: Cellcept;Drug: Prednisone<br>* IV<br>|
| Active Comparator: 2<br>Standard steroid maintenance | Drug: Tacrolimus<br>* IV<br>* Other names: FK506;Drug: mycophenolate mofetil<br>* IV<br>* Other names: Cellcept;Drug: Prednisone<br>* IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR) |  | 3 months post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy proven chronic allograft nephropathy(CAN) |  | 2 years post transplant | 
| Patient and graft survival rates |  | End of study (5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Efficacy, Treatment Effectiveness, Anti-rejection therapy, Immunosuppression, Antirejection, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney, Grafting, Kidney