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Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476488
First Posted: November 22, 2011
Last Update Posted: May 27, 2015
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.
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital
  Purpose

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: 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

Resource links provided by NLM:


Further study details as provided by Jongwon Ha, 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

Study Start Date: July 2011
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Advagraf
single group, conversion of prograf to advagraf
Drug: tacrolimus
Other Names:
  • Prograf
  • Advagraf

  Eligibility

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
  Contacts and Locations
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
  More Information

Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01476488     History of Changes
Other Study ID Numbers: Adva01SNUH
First Submitted: July 22, 2011
First Posted: November 22, 2011
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