A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients

Brief description of study

The purpose of this research study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance) in kidney transplant recipients with chronic active antibody-mediated rejection (CABMR). Clazakizumab is an investigational drug being developed by Vitaeris Inc. (Vitaeris) for the treatment of chronic active antibody-mediated rejection (CABMR) in kidney transplant recipients. An investigational drug is one that has not been approved by the regulatory authorities such as the US Food and Drug Administration (FDA). Clazakizumab is an antibody drug (a protein made in yeast) that blocks another protein called interleukin 6 (IL-6) which is important in inflammation and may be responsible for the development of antibody-mediated rejection in patients who have received a kidney transplant. To date, over 1,000 people (healthy volunteers, patients with rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, graft-versus-host disease, advanced cancer, highly sensitized patients awaiting a kidney transplant and CABMR) have taken this investigational drug in clinical studies. The study will test whether or not clazakizumab can slow or prevent the decline in the working of your transplanted kidney and lengthen the time before you will need to go back on dialysis or get a new kidney. Clazakizumab or placebo will be given subcutaneously (injections under the skin) once every 4 weeks.

Clinical Study Identifier: s18-00987
ClinicalTrials.gov Identifier: NCT03744910

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