Special Access for the Use of Voclosporin for Kidney Transplantation

NCT01236287 | Unknown

• 1 other identifier: 0904010380
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Immunosuppression; Transplantation, Kidney

Interventions

Voclosporin DRUG

Subjects will receive voclosporin capsules, twice daily

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College/NewYork-Presbyterian Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

voclosporin

Study Officials

• Sandip Kapur, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 8, 2010
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (1)