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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00717678

Collaborator

Astellas Pharma Taiwan, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

14.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Transplantation Immunology Host vs Graft Reaction	Drug: Prograf-XL Drug: Prograf Drug: MMF	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prograf-XL + MMF	Drug: Prograf-XL oral Other Names: tacrolimus extended release FK506XL MR4 Drug: MMF oral Other Names: Mycophenolate Mofetil
Active Comparator: Prograf + MMF	Drug: Prograf oral Other Names: tacrolimus FK506 Drug: MMF oral Other Names: Mycophenolate Mofetil

Arm

Intervention/Treatment

Experimental: Prograf-XL + MMF

Drug: Prograf-XL

oral

Other Names:

tacrolimus extended release

FK506XL

MR4

Drug: MMF

oral

Other Names:

Mycophenolate Mofetil

Active Comparator: Prograf + MMF

Drug: Prograf

oral

Other Names:

tacrolimus

FK506

Drug: MMF

oral

Other Names:

Mycophenolate Mofetil

Outcome Measures

Primary Outcome Measures

The patient and graft survival rates at 6 month post-transplant [6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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