A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients

Study Overview
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Brief Summary
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To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients

Official Title
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A PHASE III, Randomized, Open-Label, Comparative, Multi - Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Kidney Transplant Recipients

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Prograf
* Drug: MR4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment Exclusion Criteria: Patient has previously received an organ transplant other than a kidney Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor Patients has received an ABO incompatible donor kidney Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV) Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant) Patient has a known hypersensitivity to tacrolimus Patient is pregnant or lactating

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 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> | Drug: Prograf<br>* oral<br>* Other names: FK506;|
| Experimental: 2<br> | Drug: MR4<br>* oral<br>* Other names: FK506E;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rejection within 24 weeks (6 months) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1) |  | at 6 months | 
| Time to first acute rejection episode |  | for 6 months | 
| 6 month patient and graft survival rate |  | at 6 months | 
| Severity of acute rejection |  | 6 months | 
| Adverse events, laboratory parameters and vital signs |  | Throughout trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organ Transplantation, Tacrolimus, Prograf, FK506MR