Status:
TERMINATED
MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
De Novo Kidney Transplant
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen o...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay).
- Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression.
- Exclusion criteria
- Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ.
- Kidneys from non-heart beating donors.
- ABO incompatibility against the donor.
- Patients with panel reactive antibodies of \>50% at most recent assessment prior to transplantation and /or prior graft lost due to immunological reasons in the first six months post-transplantation or patients who are considered to be at increased risk of acute rejection by the principal investigator Additional protocol defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00284921
Start Date
April 1 2004
Last Update
November 2 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.