Isotechnika Pharma Inc IPHAF

good news for those patients

[labumba]

Special Access for the Use of Voclosporin for Kidney Transplantation

Expanded access is currently available for this treatment.

Verified by Weill Medical College of Cornell University, November 2010

First Received: November 4, 2010 Last Updated: November 5, 2010 History of Changes

Sponsor:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT01236287

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:

MedlinePlus related topics: Kidney Transplantation

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