The primary objective is to evaluate whether NULOJIX® (belatacept), when implemented with gradual tacrolimus withdrawal over 9 months, is safe with respect to preventing the composite endpoint of acute cellular rejection (ACR) > ISHLT 2R, hemodynamic compromise rejection in the absence of a biopsy or histological rejection, re-transplantation, and death at 18 months post-transplant. The secondary clinical objective is to evaluate the effect of NULOJIX® (belatacept) with gradual tacrolimus withdrawal over 9 months on kidney function, HLA antibodies, and various rejection endpoints. The secondary safety objectives will evaluate the incidence of serious infections, PTLD, malignancies, re-listing or re-transplantation, death, as well as the tolerability of belatacept-based therapy.
What is the full name of this clinical trial?
Belatacept with delayed tacrolimus withdrawal versus standard-of-care tacrolimus in heart transplant recipients
Other
Kobashigawa, Jon
Adult
II
STUDY00003681
NCT06478017
Other
Kobashigawa, Jon
Adult
II
RTB-013
NCT06478017