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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: November 17, 2011
Last verified: November 2011
History of Changes
  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: 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:

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

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

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01476488     History of Changes
Other Study ID Numbers: Adva01SNUH
Study First Received: July 22, 2011
Last Updated: November 17, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013