Status:
COMPLETED
Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Europe B.V.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compar...
Detailed Description
The use of tacrolimus-based primary immunosuppression in elderly renal transplant recipients is efficacious and safe, particularly in combination with MMF, and seems to be associated with lower mortal...
Eligibility Criteria
Inclusion
- Patients with minimum 60 years of age and end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.
Exclusion
- Patient has an immunological high risk
- Cold ischemia time greater than 30 hours.
- Patient has significant liver disease
- Patient is allergic or intolerant to study medication
- Patient or donor is known to be HIV positive.
- Patient with malignancy or history of malignancy
- Patient has significant, uncontrolled concomitant infections
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00296309
Start Date
October 1 2004
End Date
August 1 2006
Last Update
September 1 2014
Active Locations (33)
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1
Brussels, Belgium, 1200
2
Leuven, Belgium, 3000
3
Bordeaux, France, 33076
4
Clermont-Ferrand, France, 63003