Weill Medical College of Cornell University – Immunosuppression

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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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