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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00481819

Collaborator

(none)

240

Enrollment

Locations

Arms

Duration (Months)

26.7

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: FK506MR Drug: Prograf Drug: Mycophenolate Mofetil Drug: Methylprednisolone Drug: Prednisolone	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study.

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 In combination with MMF and steroids	Drug: FK506MR oral Other Names: Advagraf Tacrolimus modified-release MR4 Drug: Mycophenolate Mofetil oral Other Names: MMF Drug: Methylprednisolone oral Drug: Prednisolone oral
Active Comparator: 2 In combination with MMF and steroids	Drug: Prograf oral Other Names: tacrolimus FK506 Drug: Mycophenolate Mofetil oral Other Names: MMF Drug: Methylprednisolone oral Drug: Prednisolone oral

Arm

Intervention/Treatment

Experimental: 1

In combination with MMF and steroids

Drug: FK506MR

oral

Other Names:

Advagraf

Tacrolimus modified-release

MR4

Drug: Mycophenolate Mofetil

oral

Other Names:

MMF

Drug: Methylprednisolone

oral

Drug: Prednisolone

oral

Active Comparator: 2

In combination with MMF and steroids

Drug: Prograf

oral

Other Names:

tacrolimus

FK506

Drug: Mycophenolate Mofetil

oral

Other Names:

MMF

Drug: Methylprednisolone

oral

Drug: Prednisolone

oral

Outcome Measures

Primary Outcome Measures

Event rate of patients with acute rejections [12 weeks]

Secondary Outcome Measures

Incidence of and time to acute rejections [12 Weeks]
Overall frequency of acute rejections [12 Weeks]
Rate of patient and graft survival following transplantation [12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent with the date of the patient must be obtained.
Patient between 18-70 years of age receiving the primary kidney.
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:

Kidney re-transplantation patients or received an organ transplantation other than a kidney.
PRA>10% in the previous 6 months.
Patient who need antibody induction therapy.
Patient with significant liver disease, defined as having continuously elevated >2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.
Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.
Patient is HIV or HBsAg positive.
Patient is allergic to Prograf or macrolide antibiotics.

Contacts and Locations

Locations

	Site	City	State	Country
1	3 Sites	Beijing	Beijing	China
2		Fuzhou	Fujian	China
3	2 Sites	Guangzhou	Guangdong	China
4		Wuhan	Hubei	China
5		Changsha	Hunan	China
6		Shenyang	Liaoning	China
7	2 Sites	Shanghai	Shanghai	China
8		Chongqing	Sichuan	China
9		Hangzhou	Zhejiang	China