Status:
COMPLETED
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased ren...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
- The renal cold ischemic time (CIT) must be \<30 hours
- The age of the donor must be between 10 and 65 years
- Exclusion Criteria
- Patients who have previously received an organ transplant
- Patients who are recipients of a multiple organ transplants
- Recipients of non heart-beating donor organs
- ABO incompatibility against the donor
- Other protocol-defined exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00229138
Start Date
September 1 2005
End Date
March 1 2007
Last Update
February 7 2017
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936