Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys

Study Overview
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Brief Summary
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The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with daclizumab) in recipients of marginal donor kidneys.

Detailed Description
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An open, multicentre, randomized, parallel group study to compare in marginal old-for-old renal transplant patients the safety and efficacy of two treatments: sequential mycophenolate mofetil/delayed tacrolimus plus steroids vs tacrolimus plus mycophenolate mofetil, in patients requiring induction with anti-IL2 monoclonal antibody. Elderly (≥50 years) low risk patients (PRA grade ≤50%, in the previous 6 months) receiving an allograft transplantation of marginal kidney(s) from elderly (>65 years) donors (old-for-old allocation) will be randomized to one of the following treatment arms: Arm1: Sequential mycophenolate mofetil/tacrolimus/steroids Arm2: Tacrolimus/mycophenolate mofetil/steroid one single dose (perioperatively)

Official Title
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An Open, Multicentre, Randomised, Parallel Group Study to Compare in Marginal Old-for-old Renal Transplant Patients the Safety and Efficacy of Two Treatments: Sequential Mycophenolate Mofetil/Delayed Tacrolimus Plus Steroids vs Tacrolimus Plus Mycophenolate Mofetil in Patients Requiring Induction With Anti-IL2 Antibody

Conditions
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KIDNEY TRANSPLANTATION

Intervention / Treatment
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* Drug: tacrolimus
* Drug: mycophenolate mofetil
* Drug: steroids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients minimum 60 years of age undergoing a cadaveric kidney transplant Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation. Donors older than 60 years Female patients of child bearing age agree to practice effective birth control during the study. Patient has been fully informed and has given written informed consent Exclusion Criteria: Patient has significant, uncontrolled, concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer Patient has previously received or is receiving an organ transplant other than kidney or a kidney retransplant Any pathology or medical condition that can interfere with this protocol study proposal Other exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>oral | Drug: tacrolimus<br>* immunosuppression<br>* Other names: FK506;Drug: mycophenolate mofetil<br>* oral<br>* Other names: MMF;|
| Experimental: 2<br>oral | Drug: tacrolimus<br>* immunosuppression<br>* Other names: FK506;Drug: mycophenolate mofetil<br>* oral<br>* Other names: MMF;Drug: steroids<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated creatinine clearance |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Rejection, patient survival, graft survival |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MARGINAL KIDNEY, TACROLIMUS, IMMUNOSUPPRESSION, ELDERLY RECEPIENTS