- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01236287
Special Access for the Use of Voclosporin for Kidney Transplantation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Starting at the month 144 visit, subjects sign an informed consent addendum, which describes the change to annual study visits moving forward. The subjects will continue to receive their current dose of voclosporin without therapeutic drug monitoring and will be followed in an outpatient setting. Patient and graft survival data will be collected on an annual basis for safety reporting.
Study Type
Contacts and Locations
Study Contact
- Name: Meredith J Aull, Pharm.D.
- Phone Number: (212) 746-5330
- Email: mea9008@med.cornell.edu
Study Locations
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New York
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New York, New York, United States, 10065
- Available
- Weill Cornell Medical College/NewYork-Presbyterian Hospital
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Contact:
- Meredith J Aull, Pharm.D.
- Phone Number: 212-746-0727
- Email: mea9008@med.cornell.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Principal Investigator: Sandip Kapur, MD, Weill Medical College of Cornell University
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0904010380
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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