The study on the efficacy and safety of pharmacokinetics of mycophenolate mofetil for pediatric renal transplantatio
Not Applicable
- Conditions
- pediatric renal transplantation
- Registration Number
- JPRN-UMIN000000541
- Lead Sponsor
- Japanese Study group of Pediatric Renal Transplantation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1. The acute rejection after renal transplantation. 2. Use ofimmunosuppressant which works the same way as MMF does. 3. Prior exposure to live vaccine within one month before the treatment of MMF 4. Active peptic ulcer disease 5. Severe liver dysfunction 6. Leucopenia at study entry 7. Active systemic infection 8. Malignancy 9. Hemorrhagic diathesis 10. Refractory diarrhea 11. Medical history of severe allergy or drug hypersensitivity 12. ABO-incompatible kidney allograft 13. Anti-donor antibody positive patients 14. Pregnancy 15. Judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the proportion of patients experiencing a rejection episode within the first 6 months post-transplantation
- Secondary Outcome Measures
Name Time Method 1.the proportion of patients who kept their graft by 12 months post-transplantation. 2.the proportion of patients who lived at 12 months post-transplantation. 3.the proportion of patients experiencing a biopsy-proven rejection episode at 12 months post-transplantation.