Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

Seoul National University Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Kidney Transplantation Pediatric Patients Maintenance With Tacrolimus

Interventions

tacrolimusDRUG

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24)

The investigator will compare the changes in AUC0-24 of tacrolimus, Cmax, Tmax and correlation between C0 and Cmax

Secondary Outcomes

Number of Participants with Adverse Event

Data from ClinicalTrials.gov

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