NCT00284947

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation
• Adverse Effects

Interventions

Type	Name	Description
DRUG	basiliximab	40 mg once every 28 days intravenously for 24 weeks
DRUG	MMF/EC-MPS	1g MMF or 720mg EC-MPS p.o twice daily
DRUG	Corticosteroids	Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-02-01
• Last updated: 2017-03-29

Locations

1 site across 1 country: Switzerland