Status:
COMPLETED
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney de Novo Transplant
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability an...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female patients undergoing first kidney transplant.
- Patients aged 18 -70 years.
- Patients receiving an ABO identical or compatible graft. Exclusion Criteria
- Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
- Positive HBsAg test
- Pre-Transplant PRA \>50% or historical PRA \>75% Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00238992
Start Date
December 1 2002
Last Update
November 2 2011
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