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NCT01476488 Clinical Trial

Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:
Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01476488
Other study ID # Adva01SNUH
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received July 22, 2011
Last updated May 24, 2015
Start date July 2011

Study information
Verified date May 2015
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 15 Years
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tacrolimus

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Number of Participants with Adverse Event Yes
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