Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital Identifier:
First received: July 22, 2011
Last updated: July 18, 2013
Last verified: July 2013

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.

Condition Intervention Phase
Kidney Transplantation
Pediatric Patients
Maintenance With Tacrolimus
Drug: tacrolimus
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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:
  • Number of Participants with Adverse Event [ Designated as safety issue: Yes ]

Study Start Date: July 2011
Arms Assigned Interventions
No Intervention: Advagraf
single group, conversion of prograf to advagraf
Drug: tacrolimus
Other Names:
  • Prograf
  • Advagraf


Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01476488

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Jongwon Ha, MD, PhD Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital Identifier: NCT01476488     History of Changes
Other Study ID Numbers: Adva01SNUH
Study First Received: July 22, 2011
Last Updated: July 18, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA) processed this record on March 31, 2015