Phase 3 trial assesses clazakizumab in kidney transplant recipients with caAMR

Persistent energetic antibody-mediated rejection (caAMR) is a standard reason for allograft loss after transplantation, with no authorised therapies. Clazakizumab, a monoclonal antibody that targets the inflammatory cytokine interleukin-6 (IL-6), stabilized kidney transplant recipients’ kidney perform in a part 2 trial. Investigators now have information from a part 3 trial with clazakizumab. The findings from the Section 3 IMAGINE trial, the most important placebo-controlled examine in kidney transplant recipients with caAMR, will be introduced at ASN Kidney Week 2024 October 23– 27.

The worldwide IMAGINE double-blind part 3 trial was the primary examine in transplantation to have a fairly seemingly surrogate endpoint (1-year estimated glomerular filtration price [eGFR] slope-;a measure of adjustments in kidney perform) accepted by the U.S. Meals and Drug Administration. The trial aimed to recruit roughly 350 kidney transplant recipients with cAMR, randomized 1:1 to clazakizumab or placebo. 

In an interim evaluation performed when roughly 100 individuals accomplished 1 12 months of the examine, unbiased investigators discovered that the examine was unlikely to satisfy the first efficacy consequence (time to a composite of all-cause allograft loss or irreversible lack of allograft perform), and the info and security monitoring board really helpful to cease the examine. 

The ultimate evaluation following early termination after 1-year interim evaluation of eGFR confirmed that there was no distinction in Least Squares imply change from baseline in eGFR at week 52 for clazakizumab in contrast with placebo. There have been no security considerations noticed within the examine.

Treating sufferers with caAMR stays a problem, and whereas we’re upset by these outcomes, we’ll proceed to advance analysis for kidney transplant sufferers. We need to prolong our gratitude to all these concerned within the trial, together with our sufferers, analysis websites and examine sponsor, CSL, for his or her dedication to addressing the unmet wants of those sufferers.”

Arjang Djamali, MD, corresponding creator of Maine Medical Heart

Examine: “Clazakizumab in Persistent Energetic Antibody-Mediated Kidney Transplant Rejection: Outcomes of the IMAGINE Section 3 Examine”