Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Antibodies, Monoclonal; Basiliximab; Calcineurin Inhibitors; Methylprednisolone; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisone

Criteria

Inclusion Criteria:

• Patients with a first kidney transplant from a living or deceased donor at least 12 months after transplantation.

• Patients receiving CNI, mycophenolic acid (MPA) and oral corticosteroids.

• Patients who are able to tolerate full dose MPA.

• Patients with glomerular filtration rate (GFR) > 30 mL/min.

• Patients without an acute rejection episode during the preceding 6 months.

• Patients with signs or symptoms of CNI intolerance (renal dysfunction, poor blood pressure control, diabetes, poor lipid control, hyperuricemia and gout, significant hypophosphatemia or hypomagnesemia, gingival hyperplasia, hypertrichosis, etc.) in whom CNI interruption is justified.

Exclusion Criteria:

• Patients with preformed positive skin test against basiliximab

• Patients with preformed panel reactive antibody (PRA) > 10%.

• Signs of active immune process on graft biopsy.

• Patients with multi-organ or second kidney transplant

Other protocol-defined inclusion/exclusion criteria may apply.