Special Access for the Use of Voclosporin for Kidney Transplantation

Expanded access is currently available for this treatment.
Verified July 2015 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 9, 2015
Last verified: July 2015
  Purpose
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.

Condition Intervention
Immunosuppression
Transplantation, Kidney
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:


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.
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 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.

Subjects will receive voclosporin and will be followed in an outpatient setting. After their initial visit, patients will return for follow-up at least every 3 months (through month 24) and then every 6 months (beginning at month 24). Safety and efficacy measurements will be taken at appropriate time points as outlined in the table below. Trough voclosporin measurements will be collected at least every 3 months (through month 24) and then every 6 months (beginning at month 24) or more frequently at clinic visits as appropriate (as indicated by clinical events (such as rejection, infection, adverse event) or concomitant administration of an interacting medication. Patient and graft survival data will be collected on an annual basis for safety reporting.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 9, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 24, 2016