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Special Access for the Use of Voclosporin for Kidney Transplantation

Expanded access is currently available for this treatment.
Verified July 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Sandip Kapur, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01236287
First received: November 4, 2010
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

Voclosporin is an investigational medication being 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.


Condition Intervention
Kidney Transplantation
Immunosuppression
 Drug: Voclosporin

Study Type: Expanded Access     What is Expanded Access?
Official Title: Special Access for the Use of Voclosporin for Kidney Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Intervention Details:
    Drug: Voclosporin
    Subjects will receive voclosporin capsules, twice daily to maintain a trough level > 20 ng/mL.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236287

Contacts
Contact: Meredith J Aull, Pharm.D. (212) 746-5330 mea9008@med.cornell.edu

Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Sandip Kapur, Associate Professor of Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01236287     History of Changes
Other Study ID Numbers: 0904010380
Study First Received: November 4, 2010
Last Updated: July 3, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cyclosporine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013