drugset / Trial / NCT00284947

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

NCT00284947

Phase 4 Completed 7 enrolled Novartis
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2006-01
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Basiliximab Monoclonal antibody 40 mg Intravenous
Background MMF Unknown 1 g Oral
Background Methylprednisolone Other / unclassified
Background Prednisone Other / unclassified 5 mg Oral
Background Prednisone Other / unclassified 10 mg Oral
Background mycophenolic acid Small molecule 720 mg Oral

Indications

No indication recorded.