EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function
Recruitment status was: Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.
- To demonstrate that the efficacy of basiliximab compared to the efficacy of tacrolimus kis comparable in the prevention of acute cellular rejection at 3 and 12 months after baseline.
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||April 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302497
|MUHC Royal Victoria Hospital|
|Montreal, Quebec, Canada, H3A 1A1|
|Principal Investigator:||jean tchervenkov, MD||Royal Victoria Hospital, Canada|