Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate kidney graft function in maintenance renal transplant patients.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid

Criteria

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