A Study to Compare the Efficacy and Safety of FK506MR vs... | NCT00459719

Studies
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation

NCT00459719

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Feb 24, 2016Estimated

Enrollment

42Actual

Phase

Phase 3

Conditions

Liver Transplantation

Interventions

Tacrolimus modified-release
Prograf

Countries

China

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

Feb 2016

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

Mar 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Apr 10, 2007

First Submission Date that Met QC Criteria

Apr 11, 2007

First Posted Date

Apr 12, 2007Estimated

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

Feb 23, 2016

Last Update Posted Date

Feb 24, 2016Estimated

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

The patients about to undergo liver transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	In combination with steroids	Drug: Tacrolimus modified-release
2	Active Comparator	In combination with steroids	Drug: Prograf

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus modified-release	Drug	oral	1	Advagraf FK506MR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Event rate of patients with acute rejections		12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidence of and time to acute rejections		12 Weeks
Overall frequency of acute rejections		12 Weeks
Rate of patient and graft survival following transplantation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent with the date of the patient must be obtained.
Patient between 18-70 years of age receiving the primary liver.
Female patients must have a negative pregnancy test prior to the enrolment.
Female patients of child bearing potential must agree to practice effective birth control during the study

Exclusion Criteria:

Liver re-transplantation patients or received an organ transplantation other than a liver.
Living-related liver transplantation patient.
Patient has received an AB0 incompatible donor liver.
Patient who needs antibody induction therapy.
Patient with sever infection requiring treatment.
Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prof. Leng Xisheng	Department of Hepatobiliary surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016559	Tacrolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided