Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.

• Phase: Phase 2
• 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.

• Patients must be receiving a first cadaveric or living donor renal transplant.

• Patients must be able to receive oral medication at time of randomization.

• Females who are not 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 practicing a highly effective method of birth control. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin.

• Able to give written informed consent prior to screening procedures.

• Able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator.

Exclusion Criteria:

• Receiving a HLA (human leukocyte antigen)identical living related transplant.

• Cold ischemic time > 24 hours.

• Peak PRA (panel reactive antibodies) > 30%

• Cadaveric donors who are over age 60, non-heart beating donors, or any cadaveric donors positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).

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

• Systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against cytomegalovirus [CMV] and/or pneumocystis carinii pneumonia (PCP) infection will be permitted).

• Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus. Known negative serology prior to study entry may be used.

• 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 electrodesiccation.

• Requires prohibited medications or treatment during the study.

• Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) ≥ 3x upper limit of normal (ULN) at time of transplantation.

• White blood cell count ≤ 2.8 x 10^9/L.

• Triglycerides ≥ 3x ULN.

• Pregnant women or nursing mothers.

• Has used any investigational drug or device within 28 days or 5 half lives (whichever is longer) prior to enrollment.

• Previous exposure to voclosporin.

• A history of active alcoholism or drug addiction within 1 year prior to study entry.

• Weighs < 45 kg (99 lbs) or > 140 kg (308 lbs).

• A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the investigator.

• Allergy to iodine.