Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

Completed · Phase 2

Conditions studied: Kidney Diseases

In brief

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

Key facts

Study ID

NCT00270634

Run by

Aurinia Pharmaceuticals Inc.

People needed

334

Starts

2006-01-01

Expected to finish

2009-07-01

Last updated by the study team

2013-02-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Isotechnika Investigational Site — Birmingham, Alabama, United States
• Isotechnika Investigational Site — Los Angeles, California, United States
• Isotechnika Investigational Site — Los Angeles, California, United States
• Isotechnika Investigational Site — Los Angeles, California, United States
• Isotechnika Investigational Site — Orange, California, United States
• Isotechnika Investigational Site — Palo Alto, California, United States
• Isotechnika Investigational Site — San Diego, California, United States
• Isotechnika Investigational Site — San Francisco, California, United States
• Isotechnika Investigational Site — Denver, Colorado, United States
• Isotechnika Investigational Site — Gainesville, Florida, United States
• Isotechnika Investigational Site — Tampa, Florida, United States
• Isotechnika Investigational Site — Chicago, Illinois, United States
• Isotechnika Investigational Site — Chicago, Illinois, United States
• Isotechnika Investigational Site — Lexington, Kentucky, United States
• Isotechnika Investigational Site — New Orleans, Louisiana, United States
• Isotechnika Investigational Site — New Orleans, Louisiana, United States
• Isotechnika Investigational Site — Baltimore, Maryland, United States
• Isotechnika Investigational Site — Boston, Massachusetts, United States
• Isotechnika Investigational Site — Ann Arbor, Michigan, United States
• Isotechnika Investigational Site — Detroit, Michigan, United States
• Isotechnika Investigational Site — Rochester, Minnesota, United States
• Isotechnika Investigational Site — Livingston, New Jersey, United States
• Isotechnika Investigational Site — Buffalo, New York, United States
• Isotechnika Investigational Site — Hawthorne, New York, United States
• Isotechnika Investigational Site — New York, New York, United States

Full record on ClinicalTrials.gov

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