Special Access for the Use of Voclosporin for Kidney Transplantation

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT01236287
Status
No Longer Available

Conditions

  • Immunosuppression
  • Transplantation, Kidney

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Voclosporin — DRUG
    Subjects will receive voclosporin capsules, twice daily

Study Details

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. Voclosporin was approved by the FDA in January 2021 for the treatment of active lupus nephritis. The sponsor (now called Aurinia Pharma, U.S.) is willing to continue to provide voclosporin (commercial supply) for the one subject remaining in this special access protocol.

Key Dates

Status verified
Jan 2025

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical College/NewYork-Presbyterian HospitalNew YorkNew York10065-

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By research site
Weill Cornell Medical College/NewYork-Presbyterian Hospital· New York, NY

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