Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

Phase 2

Completed

• Conditions: Kidney Transplantation; Pediatric Patients; Maintenance With Tacrolimus
• Interventions: Drug: tacrolimus

• Registration Number: NCT01476488
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Primary Completion: 2013-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-24
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Advagraf	tacrolimus	single group, conversion of prograf to advagraf

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants with Adverse Event

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of