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Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01476488
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital

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 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 or disease Intervention/treatment Phase
Kidney Transplantation Pediatric Patients Maintenance With Tacrolimus Drug: tacrolimus Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Actual Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Advagraf
single group, conversion of prograf to advagraf
Drug: tacrolimus
Other Names:
  • Prograf
  • Advagraf



Primary Outcome Measures :
  1. 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 :
  1. Number of Participants with Adverse Event


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476488


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

Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01476488     History of Changes
Other Study ID Numbers: Adva01SNUH
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action