NCT00302497

EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

12 Month, Prospective, Randomised, Open-Label Comparative Study to Evaluate the Protection of Kidney Function by Basiliximab in a CNI-Free Regimen in Newly Kidney Transplanted Patients (Three Months Post-Transplant) Who Are Recipient of One Kidney From Expanded Donor Criteria (UNOS Criteria)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The long-term use of calcineurin inhibitors in the maintenance phase after kidney transplantation is associated with typical adverse effects, such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities. This 15 month study with a safety follow up is undertaken to evaluate the potential benefit of an alternative treatment strategy to the chronic use of CNI. It will establish, through a comparative design, the superior protection of kidney function provided by chronic usage of basiliximab over tacrolimus early post-transplantation using EDC kidneys.

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
DRUG	basiliximab

Timeline

• Start date: 2007-04-01
• Completion: 2008-04-01
• First posted: 2006-03-14
• Last updated: 2007-04-12

Locations

1 site across 1 country: Canada