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

Astellas

Status and phase

Completed

Phase 3

Conditions

Liver Transplantation

Host vs Graft Reaction

Transplantation Immunology

Treatments

Drug: MMF

Drug: Prograf

Drug: Prograf-XL

Study type

Interventional

Funder types

Industry

Identifiers

NCT00720408

PRGXLLTx-0702-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 and steroid withdrawal in de novo Liver transplant recipients

Enrollment

48 patients

Sex

All

Ages

18 to 70 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 primary liver transplant recipient
Patient must receive first dose of XL or Prograf (or IV tacrolimus for subjects unable to tolerate oral study drug) within 48 hours of transplantation
Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant

Exclusion criteria

Patient has previously received or is receiving an organ transplant other than a liver
Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
Patient has received a liver transplant from a non-heart beating donor
Patient has received an ABO incompatible donor liver
Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria 21 and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully
Patient has fulminant hepatic failure, unless hemodynamically stable
Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
Patient has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
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, including the protocol biopsies
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