Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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 renal toxicity by reducing the overall exposure to tacrolimus.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tacrolimus

Criteria

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.