Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 / M...
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 stan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
699 Patients enrolled
Trial Details
Trial ID
NCT00189839
Start Date
August 1 2004
End Date
December 1 2006
Last Update
July 9 2014
Active Locations (80)
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1
Buenos Aires, Argentina
2
Santa Fe, Argentina
3
Melbourne, Australia
4
Sydney, Australia