Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation

Study Overview
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Brief Summary
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Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.

Official Title
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An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: Mycophenolate Mofetil
* Drug: methylprednisolone and prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation Patient is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type Exclusion Criteria: Patient has an immunological high risk, defined as having a most recently measured PRA grade of >= 50% within the previous six months Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) Patient or donor is known to be HIV positive Patient with malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer Patient is receiving a graft from a non-heart-beating donor Cold ischemia time of the donor kidney >= 40 hours

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tacrolimus/MMF/steroids throughout the study | Drug: Tacrolimus<br>* oral<br>* Other names: FK506;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: CellCept;Drug: methylprednisolone and prednisone<br>* IV and oral<br>* Other names: Steroids;|
| Experimental: 2<br>Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3 | Drug: Tacrolimus<br>* oral<br>* Other names: FK506;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: CellCept;Drug: methylprednisolone and prednisone<br>* IV and oral<br>* Other names: Steroids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and seriousness of adverse events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplantation, Graft Rejection, Renal Transplantation