Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients
NCT ID: NCT01476488
Last Updated: 2015-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
INTERVENTIONAL
2011-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Advagraf
single group, conversion of prograf to advagraf
tacrolimus
Interventions
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tacrolimus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
5 Years
15 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jongwon Ha
Professor
Principal Investigators
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Jongwon Ha, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine
Locations
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Seoul National University Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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Adva01SNUH
Identifier Type: -
Identifier Source: org_study_id
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