Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Study Overview
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Brief Summary
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To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.

Official Title
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Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Conditions
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Kidney Transplantation, Kidney Failure, Chronic, Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: Mycophenolate Mofetil
* Drug: Methylprednisolone or equivalent
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during the study Has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation Subject is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible AB0 blood type Exclusion Criteria: Pregnant woman or breast-feeding mother Has an immunological high risk, defined as having a most recently measured PRA grade of > 50% within the previous six months Known allergy to the study drug or any of its components Requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation Requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) Subject or donor is known to be HIV positive Has significant liver disease, defined as having during the past 28 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site Diagnosis of malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully Has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer Previously received or is receiving an organ transplant other than kidney Receiving a graft from a non-heart-beating donor Cold ischemia time of the donor kidney >30 hours 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>steroid regimen 1 | Drug: Tacrolimus<br>* oral<br>* Other names: FK506;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: MMF;Drug: Methylprednisolone or equivalent<br>* oral<br>Drug: Prednisone<br>* oral<br>|
| Experimental: 2<br>steroid regimen 2 | Drug: Tacrolimus<br>* oral<br>* Other names: FK506;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: MMF;Drug: Methylprednisolone or equivalent<br>* oral<br>Drug: Prednisone<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and time to first biopsy-proven acute rejection |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall frequency of acute rejection episodes within 6 months post transplantation |  | 6 months | 
| Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation |  | 6 months | 
| Incidence of and time to first corticosteroid-resistant acute rejection |  | 6 months | 
| Subject and graft survival |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organ Transplantation, Tacrolimus, Prograf, Kidney, Immunosuppression