Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aurinia Pharmaceuticals Inc.
• Treatments: Cyclosporine; Tacrolimus

Criteria

Inclusion Criteria:

• Males and females aged 18-65 years inclusive at the time of screening.

• Recipients of a first or second deceased donor or living donor renal transplant.

Exclusion Criteria:

• Subjects presently receiving immunosuppression for a previously failed transplant.

• Females who are pregnant or nursing or planning to become pregnant during the course of the study, or 3 months after last dose of study medication.

• Sexually-active women of child-bearing potential (including those who are < 1 year postmenopausal) and sexually-active men who are not practicing a highly effective method of birth control.

• Subjects receiving a HLA identical living related transplant.

• Subjects wth a positive T-cell lymphocytotoxic cross match, or positive flow T and B cell cross match.

• Subjects undergoing primary transplant with a current PRA (or CPRA) ≥ 25%.

• Subjects who experienced graft loss within 1 year of transplant.

• Subjects receiving a kidney from a ABO incompatible donor.

• Subjects receiving a kidney from a deceased donor positive for HIV, HBV, HCV or tuberculosis.

• Subjects receiving a a kidney from a non-heart beating donor.

• Subjects receiving paired (en bloc or paired) kidney transplants.

• Transplantation of multiple grafts (e.g. kidney and pancreas).

• Subjects receiving a kidney with a cold ischemia time > 30 hours.

• Subjects receiving any transplanted organ other than a kidney.

• Recipients of a bone marrow or stem cell transplant.

• Any systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against CMV and/or PCP infection will be permitted).

• Subjects with positive results of the following serological tests: HIV I Ab, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and the anti-hepatitis C virus antibody (HCV Ab). Negative results for these serological tests must be documented within 12 months prior to randomization.

• Subjects with active tuberculosis (Tb) requiring treatment within the last 3 years. Subjects with a known positive purified protein derivative (PPD) test are not eligible unless they have completed treatment for latent Tb and have a negative chest X-ray at time of enrollment. PPD testing must have been done within the last 12 months, and a positive result is defined as ≥ 10 mm induration, a Heaf score of >1 in non-Bacille Calmette-Guérin (BCG) immunized subjects, or >2 in BCG immunized subjects.

• Subjects with a current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodessication.