Special Access for the Use of Voclosporin for Kidney Transplantation
Available
Weill Medical College of Cornell University
1969-12-31
Voclosporin is an investigational medication previously studied to prevent acute rejection in
patients who receive a kidney transplant. This study is a compassionate release program where
subjects previously participating in the study entitled A Phase 2B, Randomized, Multicenter,
Open-Label, Concentration Controlled, Safety Study of ISA247 and Tacrolimus (Prograf®) in
denovo Renal Transplant Patients (ISA05-01)" may be eligible to continue to receive
voclosporin despite the Phase 2B study being terminated by the sponsor. Under the
compassionate release program, subjects previously taking voclosporin may continue to receive
the study medication until the drug is FDA-approved and commercially available in the United
States.
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