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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000541
Enrollment
50
Registered
2007-01-05
Start date
2007-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pediatric renal transplantation

Interventions

Mycophenolate mofetil

Sponsors

Japanese Study group of Pediatric Renal Transplantation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Recipients of a first kidney allograft from a living or cadaver donor 2. Patients under the age of 20 3.Written informed consent from the patients' parents or legal guardians 4. Patients who are able to go to hospital during therapy of the trial

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
the proportion of patients experiencing a rejection episode within the first 6 months post-transplantation

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactMayumi Sako

National Center for Child Health and Development Department of Nephrology

sako-m@ncchd.go.jp03-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026