Conversion of Prograf to Advagraf in Pediatric Renal Tran... | NCT01476488

Studies
Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

NCT01476488

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

Not provided

Phase

Phase 2Phase 3

Conditions

Kidney Transplantation
Pediatric Patients
Maintenance With Tacrolimus

Interventions

tacrolimus

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Not provided

First Submitted Date

Jul 22, 2011

First Submission Date that Met QC Criteria

Nov 17, 2011

First Posted Date

Nov 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2015

Last Update Posted Date

May 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Advagraf	No Intervention	single group, conversion of prograf to advagraf	Drug: tacrolimus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tacrolimus	Drug		Advagraf	Prograf Advagraf

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of Participants with Adverse Event

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jongwon Ha, MD, PhD	Seoul National University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Seoul	110-744	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D016559	Tacrolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

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Browse Branches

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