Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Study Overview
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Brief Summary
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Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.

Official Title
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A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids

Conditions
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Graft Rejection, Kidney Failure, Kidney Transplantation

Intervention / Treatment
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* Drug: tacrolimus
* Drug: mycophenolate mofetil
* Drug: methylprednisolone
* Drug: prednisolone
* Drug: sirolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 and < 65 years End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant Exclusion Criteria: Evidence of active systemic or localized major infection at the time of initial sirolimus administration Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tacrolimus|nan|
|Drug: mycophenolate mofetil|nan|
|Drug: methylprednisolone|nan|
|Drug: prednisolone|nan|
|Drug: sirolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post- |  |  | 
| transplantation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff |  |  | 
| criteria at 3, 6 and 12 Months following transplantation |  |  | 
| One year graft biopsy status |  |  | 
| Incidence of document infection |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplant