A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The patients about to undergo kidney transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tacrolimus

Criteria

Inclusion Criteria:

• Written informed consent with the date of the patient must be obtained.

• Patient between 18-70 years of age receiving the primary kidney.

• Female patients must have a negative pregnancy test prior to the enrolment.

• Female patients of child bearing potential must agree to practice effective birth control during the study.

Exclusion Criteria:

• Kidney re-transplantation patients or received an organ transplantation other than a kidney.

• PRA>10% in the previous 6 months.

• Patient who need antibody induction therapy.

• Patient with significant liver disease, defined as having continuously elevated >2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.

• Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.

• Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.

• Patient is HIV or HBsAg positive.

• Patient is allergic to Prograf or macrolide antibiotics.