Status:
TERMINATED
Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study will evaluate kidney graft function in maintenance renal transplant patients.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
- Age \> 18 yrs
- Adequate and stable renal function
- Informed consent.
- Exclusion criteria:
- Kidney transplant combined with other organs;
- Significant proteinuria
- Severe ongoing infections;
- Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
- Relapse of the end-stage renal disease on the transplanted kidney;
- Leucopenia, thrombocytopenia or severe anemia;
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00434590
Start Date
March 1 2007
End Date
May 1 2008
Last Update
April 7 2011
Active Locations (1)
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1
Novartis Investigative Site
Bologna, Italy