Status:
COMPLETED
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
Lead Sponsor:
Astellas Pharma Inc
Conditions:
KIDNEY TRANSPLANTATION
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil \[MMF\] plus steroids versus tacrolimus plus MM...
Detailed Description
An open, multicentre, randomized, parallel group study to compare in marginal old-for-old renal transplant patients the safety and efficacy of two treatments: sequential mycophenolate mofetil/delayed ...
Eligibility Criteria
Inclusion
- Male or female patients minimum 60 years of age undergoing a cadaveric kidney transplant
- Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation.
- Donors older than 60 years
- Female patients of child bearing age agree to practice effective birth control during the study.
- Patient has been fully informed and has given written informed consent
Exclusion
- Patient has significant, uncontrolled, concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
- Patient has previously received or is receiving an organ transplant other than kidney or a kidney retransplant
- Any pathology or medical condition that can interfere with this protocol study proposal
- Other exclusion criteria apply
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00321113
Start Date
September 1 2004
End Date
March 1 2008
Last Update
February 24 2017
Active Locations (14)
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1
Bologna, Italy, 40138
2
Cagliari, Italy, 09134
3
Milan, Italy, 30100
4
Modena, Italy, 41100