Status:
COMPLETED
Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients
Lead Sponsor:
Seoul National University Hospital
Conditions:
Kidney Transplantation
Pediatric Patients
Eligibility:
All Genders
5-15 years
Phase:
PHASE2
PHASE3
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 tacro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01476488
Start Date
July 1 2011
Last Update
May 27 2015
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Seoul, South Korea, 110-744