Status:
COMPLETED
Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
Lead Sponsor:
Novartis
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sod...
Eligibility Criteria
Inclusion
- Primary donor kidney transplant
- Panel reactive antibody (PRA) ≤ 20%
Exclusion
- Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney
- Non-heart beating donor or kidney from a non-compatible donor
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00413920
Start Date
April 1 2007
Last Update
April 21 2011
Active Locations (1)
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1
C.H.U. La Milétrie
Poitiers, France