NCT01476488

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

July 22, 2011

Last Update Submit

May 24, 2015

Conditions

Kidney TransplantationPediatric PatientsMaintenance With Tacrolimus

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Number of Participants with Adverse Event

Study Arms (1)

Advagraf

NO INTERVENTION

single group, conversion of prograf to advagraf

Drug: tacrolimus

Interventions

tacrolimusDRUG
Also known as: Prograf, Advagraf
Advagraf

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ABO-compatible kidney-only transplantation
  • more than 1 year after kidney transplantation
  • to 15 years old
  • patients maintained on Prograf
  • tacrolimus level of determined previously: 4 to 20 ng/ml
  • eGFR by Schwartz equation \> 50mL/min

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Jongwon Ha, MD, PhD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2011

First Posted

November 22, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2013

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

KR(1)