Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01476488
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital

July 22, 2011
November 22, 2011
May 27, 2015
July 2011
March 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01476488 on Archive Site
Number of Participants with Adverse Event
Same as current
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Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients
Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients

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.

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Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Kidney Transplantation
  • Pediatric Patients
  • Maintenance With Tacrolimus
Drug: tacrolimus
Other Names:
  • Prograf
  • Advagraf
No Intervention: Advagraf
single group, conversion of prograf to advagraf
Intervention: Drug: tacrolimus
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 15 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Jongwon Ha, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Jongwon Ha, MD, PhD Seoul National University College of Medicine
Seoul National University Hospital
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP