The study on the efficacy and safety of pharmacokinetics of mycophenolate mofetil for pediatric renal transplantation

UMIN ID: UMIN000000541

Registered date:05/01/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: pediatric renal transplantation
• Date of first enrollment: 2007/01/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Mycophenolate mofetil

Outcome(s)

• Primary Outcome: the proportion of patients experiencing a rejection episode within the first 6 months post-transplantation
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 20years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Japanese Study group of Pediatric Renal Transplantation
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare