Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients.

Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• ABO-compatible kidney-only transplantation

• more than 1 year after kidney transplantation

• 5 to 15 years old

• patients maintained on Prograf

• tacrolimus level of determined previously: 4 to 20 ng/ml

• eGFR by Schwartz equation > 50mL/min

Exclusion Criteria:

• patients with acute rejection within 90 days

• patients with acute rejection requiring antibody therapy within 6 months

• patients with more than 2 times of acute rejection within 1 year

• AST/ALT 2 times more than upper normal limit

• ABO-incompatible or crossmatch-positive transplantation

• multiorgan transplantation