A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.

Official Title
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A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF in de Novo Kidney Transplant Recipients

Conditions
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Kidney Transplantation, Transplantation Immunology, Host vs Graft Reaction

Intervention / Treatment
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* Drug: Prograf-XL
* Drug: Prograf
* Drug: MMF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization Exclusion Criteria: Patient has previously received or is receiving an organ transplant other than a kidney Patient has received a kidney transplant from a non-heart beating donor Patient 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 or any other unstable medical condition that could interfere with the study objectives Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids Patient is pregnant or lactating Patient is unlikely to comply with the visits scheduled in the protocol Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator

Ages Eligible for Study
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Minimum Age: 12 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: Prograf-XL + MMF<br> | Drug: Prograf-XL<br>* oral<br>* Other names: MR4;Drug: MMF<br>* oral<br>* Other names: Mycophenolate Mofetil;|
| Active Comparator: Prograf + MMF<br> | Drug: Prograf<br>* oral<br>* Other names: FK506;Drug: MMF<br>* oral<br>* Other names: Mycophenolate Mofetil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patient and graft survival rates at 6 month post-transplant |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy failure at 6-month posttransplant. |  | 6 months | 
| Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months |  | 6 months and 12 months | 
| 1 year patient and graft survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunosuppressant, Combination drug therapy, Graft loss, Randomized controlled trial, Open level method