Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

Seoul National University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Maintenance With Tacrolimus; Kidney Transplantation; Pediatric Patients

Treatments: Drug: tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01476488

Adva01SNUH

Details and patient eligibility

About

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.

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Advagraf

No Intervention group

Description:

single group, conversion of prograf to advagraf

Treatment:

Drug: tacrolimus