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

Kidney Transplantation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481819
• Other study ID #: MR4KTxCN01
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2007
• Last updated: February 23, 2016
• Start date: July 2007
• Est. completion date: March 2009

Study information

• Verified date: February 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• FK506MR
oral
• Prograf
oral
• Mycophenolate Mofetil
oral
• Methylprednisolone
oral
• Prednisolone
oral

Locations

Country	Name	City	State
China	3 Sites	Beijing	Beijing
China	2 Sites	Guangzhou	Guangdong
China	2 Sites	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event rate of patients with acute rejections		12 weeks	Yes
Secondary	Incidence of and time to acute rejections		12 Weeks	Yes
Secondary	Overall frequency of acute rejections		12 Weeks	Yes
Secondary	Rate of patient and graft survival following transplantation		12 Weeks	Yes