A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients

Astellas

Status and phase

Completed

Phase 3

Conditions

Liver Transplantation

Treatments

Drug: Prograf

Drug: MR4

Study type

Interventional

Funder types

Industry

Identifiers

NCT00719745

MR-05-02-KOR

Details and patient eligibility

About

To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients of child bearing potential must have a negative in pregnancy test prior to enrollment and must agree to practice effective birth control during the study
Patients who need liver transplantation due to the end-stage liver failure

Exclusion criteria

Patients receiving multi-organ transplant or having previously received an organ transplant ( including re-transplantation)
Patients receiving auxiliary graft or in whom a bio-artificial
Patients allergic to macrolide antibiotics or tacrolimus
Patients requiring immunosuppressive treatment or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment ( MMF, steroids, azathioprine ) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed
Patients with malignancies of a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully Patients can be included under Milan Criteria Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study
Patients with systemic infection requiring treatment, except viral hepatitis
Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
Patients with serum creatinine > 1.5mg/Dl
Patients with any form of substance abuse, psychiatric disorder of condition which, in the opinion of the investigator, may complicate communication with the investigator
Patients participating or participated in another clinical trial or those taking or having taken an investigational / non-registered drug in the past 28 days
Patients who are pregnant or breast-feeding mother
Patients or donors known to be HIV positive
Patients unlikely to comply with the visits scheduled in the protocol