Status:
COMPLETED
Study of ISA247 (Voclosporin) in De Novo Renal Transplantation
Lead Sponsor:
Aurinia Pharmaceuticals Inc.
Conditions:
Kidney Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.
Detailed Description
Prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity, nephrotoxicity, polyoma nephropathy, QT prolongation, and New Onset Diabetes Mellitus After Transplant (NODAT)....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT00270634
Start Date
January 1 2006
End Date
July 1 2009
Last Update
February 12 2013
Active Locations (45)
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1
Isotechnika Investigational Site
Birmingham, Alabama, United States, 35924
2
Isotechnika Investigational Site
Los Angeles, California, United States, 90033
3
Isotechnika Investigational Site
Los Angeles, California, United States, 90057
4
Isotechnika Investigational Site
Los Angeles, California, United States, 90095-7306