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

Astellas

Status and phase

Completed

Phase 3

Conditions

Kidney Transplantation

Host vs Graft Reaction

Transplantation Immunology

Treatments

Drug: MMF

Drug: Prograf-XL

Drug: Prograf

Study type

Interventional

Funder types

Industry

Identifiers

NCT00717678

PRGXLKTx-0701-TW

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

12+ years old

Volunteers

No 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