Status:
COMPLETED
To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and ...
Detailed Description
This phase III study shall provide detailed efficacy and safety information to compare this combination of sirolimus and tacrolimus with the current standard tacrolimus combination regimen (tacrolimus...
Eligibility Criteria
Inclusion
- Patients between 18 and 60 years of age and having end stage kidney disease who will undergo 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 AB0 blood type can be included.
Exclusion
- Patient has a high immunological risk
- Cold ischemia time greater than 30 hours
- Patient has significant liver disease
- Patient has severe hypercholesterolaemia
- Patient is allergic or intolerant to study medication
- Patient requires ongoing dosing with corticosteroids.
- Patient or donor is known to be HIV positive
- Patient with malignancy or history of malignancy
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
634 Patients enrolled
Trial Details
Trial ID
NCT00296361
Start Date
October 1 2004
End Date
July 1 2006
Last Update
September 1 2014
Active Locations (59)
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1
Nedlands, Australia
2
Perth, Australia
3
Linz, Austria, 4015
4
Linz, Austria, 4020