Pharmacokinetics of Tacrolimus in Liver Transplantation P... | NCT00909571

Studies
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus

NCT00909571

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Apr 16, 2010Estimated

Enrollment

10Actual

Phase

Phase 3

Conditions

Liver Transplantation

Interventions

FK506E (modified release tacrolimus)
Prograf (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

Apr 2010

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

Apr 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

May 27, 2009

First Submission Date that Met QC Criteria

May 27, 2009

First Posted Date

May 28, 2009Estimated

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

Apr 15, 2010

Last Update Posted Date

Apr 16, 2010Estimated

Name	Class
Astellas Pharma Korea, Inc.	INDUSTRY

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

Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.

Detailed Description

To describe the pharmacokinetics of Tacrolimus when administered as two different doses of modified release formulation FK506E(MR4) combined with Prograf injection in patients undergoing primary living donor liver transplantation based on the single center (Asan Medical Center) standard protocol regimen.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. FK506E high dose group	Experimental		Drug: FK506E (modified release tacrolimus) Drug: Prograf (tacrolimus)
2. FK506E low dose group	Experimental		Drug: FK506E (modified release tacrolimus) Drug: Prograf (tacrolimus)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FK506E (modified release tacrolimus)	Drug	oral	1. FK506E high dose group 2. FK506E low dose group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of pharmacokinetic parameters		Day 6 and Day 14

Secondary Outcomes

Measure	Description	Time Frame
Incidence of acute rejection		within 12 weeks
Time to acute rejection		within 12 weeks
Assessment of graft survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving a primary partial liver graft from a living donor
Patients must receive the first dose of Tacrolimus after surgery and are expected to be maintained on Tacrolimus throughout the study

Exclusion Criteria:

Patients receiving a multi-organ transplantation or having previously received an organ transplantation
Patients receiving an auxiliary graft or in whom a bio-artificial liver has been used
Patients allergic or intolerant to macrolide antibodies or Tacrolimus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Korea, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Seoul			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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