Reducing time, sample handling, and staff requirements for complement activation monitoring in clinical trials

DESCRIPTION provided by applicant Despite overwhelming evidence that the complement system is involved in kidney and cardiovascular outcomes stringent technical requirements limit its inclusion in clinical trials and diagnostics Current protocols require careful sample collectin immediate freezing and shipping to only a few specialized labs As a result while complement system proteins C and C are routinely measured in autoimmune disease clinics proteolytically activated split products known to mediate active inflammatory and autoimmune processes are rarely assessed Kypha Inc is developing an integrated point of care POC platform to make reliable complement data more accessible to clinical trials and diagnostic applications These efforts are timely due to recent therapeutic development focused on anti inflammatory strategies including complement inhibition for extracorporeal therapies such as hemodialysis autoimmunity transplant rejection and other conditions Milestones in this Phase I proposal will demonstrate the feasibility of using advanced multiplex quantitative lateral flow assays in the point of care as a solution that decreases the resources required to measure complement activation and inflammation in clinical trials paving the way for their full utility inthe diagnosis and management of acute and chronic renal and vascular inflammatory diseases PUBLIC HEALTH RELEVANCE Complement activation is a known mediator of inflammatory renal and vascular pathophysiology However protein instability in vitro requires stringent sample handling and laboratory requirements that limit the inclusion of complement biomarkers in clinical trials Rapid simple and comprehensive complement assays will make reliable complement data more accessible This project will establish point of care biochemical data collection as a feasible approach for improving anti inflammatory clinical trials in hemodialysis and other renal conditions