NCT00154232

Study to Evaluate the Combination of Enteric-coated Mycophenolate Sodium (EC-MPS), Basiliximab, and C2-monitored Cyclosporine in de Novo Renal Transplant Recipients at Potential High Risk of Delayed Graft Function (DGF)

A 3 Month, Multicenter, Open-label Study to Evaluate the Impact of the Immunosuppressive Combination of Enteric-Coated Mycophenolate Sodium (EC- MPS), Basiliximab and Cyclosporine for Microemulsion With C2 Monitoring, on Efficacy and Safety Outcomes in de Novo Kidney Transplant Recipients at Potential High Risk of DGF.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (planned)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

Summary

The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal transplant patients at potential high risk of DGF.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Enteric-Coated Mycophenolate Sodium (EC-MPS)

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-03-01
• First posted: 2005-09-12
• Last updated: 2011-11-02