Kidney Transplantation
Conditions
Keywords
Kidney Transplantation, Tacrolimus, Methylprednisolone, Prednisolone, Mycophenolate Mofetil
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)
Interventions
DRUGFK506MR
oral
DRUGPrograf
oral
DRUGMycophenolate Mofetil
oral
DRUGMethylprednisolone
oral
DRUGPrednisolone
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event rate of patients with acute rejections | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of and time to acute rejections | 12 Weeks |
| Overall frequency of acute rejections | 12 Weeks |
| Rate of patient and graft survival following transplantation | 12 Weeks |
Countries
China
Outcome results
None listed