Kidney Transplant Clinical Trial
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)
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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