A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection

Study Overview
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Brief Summary
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To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus

Official Title
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A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Prograf®
* Drug: Advagraf®
* Drug: Mycophenolate Mofetil
* Drug: Simulect
* Drug: methylprednisolone / prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months) Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study Exclusion Criteria: Receiving or having previously received an organ transplant other than a kidney Cold ischemia time of the donor kidney > 30 hours Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest) Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s) Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation. Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer Pregnant woman or breast-feeding mother Subject or donor known to be HIV positive Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prograf + MMF + Steroids<br>oral | Drug: Prograf®<br>* oral<br>* Other names: Tacrolimus;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: MMF;Drug: methylprednisolone / prednisone<br>* oral<br>* Other names: corticosteroids;|
| Active Comparator: Advagraf (dose 1) + MMF + steroids<br>oral | Drug: Advagraf®<br>* oral<br>* Other names: Tacrolimus extended release;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: MMF;Drug: methylprednisolone / prednisone<br>* oral<br>* Other names: corticosteroids;|
| Active Comparator: Advagraf (dose 2) + MMF + steroids<br>oral | Drug: Advagraf®<br>* oral<br>* Other names: Tacrolimus extended release;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: MMF;Drug: methylprednisolone / prednisone<br>* oral<br>* Other names: corticosteroids;|
| Active Comparator: Advagraf + MMF + Basilixmab + steroids<br>oral | Drug: Advagraf®<br>* oral<br>* Other names: Tacrolimus extended release;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: MMF;Drug: Simulect<br>* oral<br>* Other names: basiliximab;Drug: methylprednisolone / prednisone<br>* oral<br>* Other names: corticosteroids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy failure rate |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function, acute rejection, Biopsy confirmed acute rejection |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney, Prograf, Transplant, Advagraf, Immunosuppression, FK506