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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Korea, Inc.
• Treatments: Tacrolimus

Criteria

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