EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function
|ClinicalTrials.gov Identifier: NCT00302497|
Recruitment Status : Unknown
Verified February 2006 by McGill University Health Center.
Recruitment status was: Not yet recruiting
First Posted : March 14, 2006
Last Update Posted : April 12, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant||Drug: basiliximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||April 2007|
|Estimated Study Completion Date :||April 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302497
|Contact: Jean Tchervenkov, MD||514 934 1934 ext firstname.lastname@example.org|
|MUHC Royal Victoria Hospital||Not yet recruiting|
|Montreal, Quebec, Canada, H3A 1A1|
|Principal Investigator: Jean Tchervenkov, MD|
|Principal Investigator:||jean tchervenkov, MD||Royal Victoria Hospital, Canada|