Special Access for the Use of Voclosporin for Kidney Transplantation

• Status: Available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Cyclosporine

Criteria

Inclusion Criteria:

• Subjects currently enrolled in "A Phase 2B, Randomized, Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 and Tacrolimus (Prograf®) in denovo Renal Transplant Patients (ISA05-01)" and has a compelling reason to remain on voclosporin

• Subjects must provide Informed Consent to participate in this study

• Females of child-bearing potential must have a negative pregnancy test prior to enrollment

Exclusion Criteria:

• Subjects who have already been switched off of voclosporin (ISA247) and on to another immunosuppressive agent