A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients

Astellas

Status and phase

Completed

Phase 3

Conditions

Kidney Transplantation

Treatments

Drug: MR4

Drug: Prograf

Study type

Interventional

Funder types

Industry

Identifiers

MR-05-01-KOR

Details and patient eligibility

About

To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients

Enrollment

135 patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure
Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment

Exclusion criteria

Patient has previously received an organ transplant other than a kidney
Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor
Patients 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(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives
Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant)
Patient has a known hypersensitivity to tacrolimus
Patient is pregnant or lactating