A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation

Study Overview
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Brief Summary
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The patients about to undergo kidney transplantation will be randomized to one of the following two group: Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)

Official Title
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A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study.

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: FK506MR
* Drug: Prograf
* Drug: Mycophenolate Mofetil
* Drug: Methylprednisolone
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent with the date of the patient must be obtained. Patient between 18-70 years of age receiving the primary kidney. Female patients must have a negative pregnancy test prior to the enrolment. Female patients of child bearing potential must agree to practice effective birth control during the study. Exclusion Criteria: Kidney re-transplantation patients or received an organ transplantation other than a kidney. PRA>10% in the previous 6 months. Patient who need antibody induction therapy. Patient with significant liver disease, defined as having continuously elevated >2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days. Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer. Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy. Patient is HIV or HBsAg positive. Patient is allergic to Prograf or macrolide antibiotics.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: 1<br>In combination with MMF and steroids | Drug: FK506MR<br>* oral<br>* Other names: MR4;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: MMF;Drug: Methylprednisolone<br>* oral<br>Drug: Prednisolone<br>* oral<br>|
| Active Comparator: 2<br>In combination with MMF and steroids | Drug: Prograf<br>* oral<br>* Other names: FK506;Drug: Mycophenolate Mofetil<br>* oral<br>* Other names: MMF;Drug: Methylprednisolone<br>* oral<br>Drug: Prednisolone<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of patients with acute rejections |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of and time to acute rejections |  | 12 Weeks | 
| Overall frequency of acute rejections |  | 12 Weeks | 
| Rate of patient and graft survival following transplantation |  | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, Tacrolimus, Methylprednisolone, Prednisolone, Mycophenolate Mofetil