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

Astellas

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: FK506MR; Drug: Prednisolone; Drug: Prograf; Drug: Mycophenolate Mofetil; Drug: Methylprednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00481819

MR4KTxCN01

Details and patient eligibility

About

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)

Enrollment: 240 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

1

Experimental group

Description:

In combination with MMF and steroids

Treatment:

Drug: Methylprednisolone

Drug: Mycophenolate Mofetil

Drug: FK506MR

Drug: Prednisolone

2

Active Comparator group

Description:

In combination with MMF and steroids

Treatment:

Drug: Methylprednisolone

Drug: Mycophenolate Mofetil

Drug: Prograf

Drug: Prednisolone