A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation
Phase 3
Completed
- Conditions
- Kidney Transplantation
- Interventions
- Registration Number
- NCT00481819
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Methylprednisolone In combination with MMF and steroids 2 Prednisolone In combination with MMF and steroids 1 Prednisolone In combination with MMF and steroids 1 FK506MR In combination with MMF and steroids 2 Prograf In combination with MMF and steroids 2 Mycophenolate Mofetil In combination with MMF and steroids 1 Mycophenolate Mofetil In combination with MMF and steroids 2 Methylprednisolone In combination with MMF and steroids
- Primary Outcome Measures
Name Time Method Event rate of patients with acute rejections 12 weeks
- Secondary Outcome Measures
Name Time Method Rate of patient and graft survival following transplantation 12 Weeks Incidence of and time to acute rejections 12 Weeks Overall frequency of acute rejections 12 Weeks
Trial Locations
- Locations (2)
2 Sites
🇨🇳Shanghai, Shanghai, China
3 Sites
🇨🇳Beijing, Beijing, China