A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189839

Enrollment

699

Registered

2005-09-19

Start date

2004-08-31

Completion date

2006-12-31

Last updated

2014-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Tacrolimus, Kidney transplantation, Transplantation, kidney, Renal Transplantation, Transplantation, renal

Brief summary

The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Detailed description

A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.

Interventions

DRUGtacrolimus

Immunosuppression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type. * Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months).

Exclusion criteria

* Patients receiving or having previously received an organ transplant other than a kidney. * Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade \>50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons. * Cold ischaemia time of the donor kidney \>30 hours.

Design outcomes

Primary

Measure	Time frame
Time to and incidence of biopsy-proven acute rejections	12 months

Secondary

Measure	Time frame
Overall rate of acute rejections	12 months

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026