Status:

NO_LONGER_AVAILABLE

Special Access for the Use of Voclosporin for Kidney Transplantation

Lead Sponsor:

Weill Medical College of Cornell University

Conditions:

Immunosuppression

Transplantation, Kidney

Eligibility:

All Genders

18-65 years

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 pre...

Detailed Description

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 pre...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01236287

Last Update

January 29 2025

Active Locations (1)

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1

Weill Cornell Medical College/NewYork-Presbyterian Hospital

New York, New York, United States, 10065