Status:
COMPLETED
Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejecti...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Recipients of de novo cadaveric, living unrelated or living related kidney transplants
- Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
- Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
- Exclusion criteria
- More than one previous renal transplantation
- Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- Patients receiving a kidney from a non-heart beating donor
- Patients who are recipients of A-B-O incompatible transplants
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00369278
Start Date
June 1 2006
End Date
December 1 2008
Last Update
March 29 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigational Site
Various Cities, Germany