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

Phase 3

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: FK506MR; Drug: Prograf; Drug: Mycophenolate Mofetil; Drug: Methylprednisolone; Drug: Prednisolone

• Registration Number: NCT00481819
• Lead Sponsor: Astellas Pharma Inc

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-31
• Study First Submitted QC: 2007-05-31
• Study First Posted: 2007-06-04
• Study Start: 2007-07
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Methylprednisolone	In combination with MMF and steroids
2	Prednisolone	In combination with MMF and steroids
1	Prednisolone	In combination with MMF and steroids
1	FK506MR	In combination with MMF and steroids
2	Prograf	In combination with MMF and steroids
2	Mycophenolate Mofetil	In combination with MMF and steroids
1	Mycophenolate Mofetil	In combination with MMF and steroids
2	Methylprednisolone	In combination with MMF and steroids

Primary Outcome Measures

Name	Time	Method
Event rate of patients with acute rejections	12 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of patient and graft survival following transplantation	12 Weeks
Incidence of and time to acute rejections	12 Weeks
Overall frequency of acute rejections	12 Weeks

Trial Locations

Locations (2)

3 Sites; 🇨🇳 Beijing, Beijing, China

2 Sites; 🇨🇳 Shanghai, Shanghai, China