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Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01476488
First received: July 22, 2011
Last updated: July 18, 2013
Last verified: July 2013

July 22, 2011
July 18, 2013
July 2011
Not Provided
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 ClinicalTrials.gov Archive Site
Number of Participants with Adverse Event [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
Not Provided
Not Provided
Not Provided

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
Both
5 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01476488
Adva01SNUH
No
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
July 2013

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