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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Taiwan, Inc.
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

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