Last updated on July 2020

Interleukin 6 Blockade Modifying Antibody-Mediated Graft Injury and Estimated Glomerular Filtration Rate (eGFR) Decline


Brief description of study

This trial investigates whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody (mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune responses.

Detailed Study Description

This multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial investigates whether clazakizumab may be beneficial for the treatment of CABMR in kidney transplant recipients by inhibiting the production of DSA and re-shaping T cell alloimmune responses. Subjects will be administered clazakizumab at a target dose of 12.5 mg (or placebo) by SC injection, Q4W for up to 260 weeks (or until graft loss or death). This "event driven" trial has been designed to evaluate the benefits of clazakizumab in prolonging the time to an all-cause composite allograft loss endpoint (primary endpoint) in patients with CABMR.

Clinical Study Identifier: NCT03744910

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WSLHD, Westmead Hospital

Westmead, Australia
0.93miles
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Recruitment Status: Open


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