Abstract TP028: Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: A Single-Center, Randomized, Open-Label, Blinded Endpoint, Controlled Study (KIF-AIS)

Background: Human urinary kallidinogenase (HUK), a proteolytic enzyme extracted from human urine, has shown promising clinical efficacy in the treatment of stroke. The pathophysiology of acute ischemic stroke (AIS) is multifactorial, with inflammation playing a pivotal role in cerebral ischemia-reperfusion injury. An increasing number of studies have shown that HUK, also known as tissue kallikrein, can inhibit inflammation. Inflammation plays a key role in both central and peripheral damage caused by ischemic stroke. However, there is still a lack of strong evidence linking the control of inflammatory factors with clinical outcomes. Methods: The KIF-AIS trial is a single-center, randomized, open-label, blinded endpoint, controlled study designed to evaluate the effects of HUK combined with standard therapy versus standard therapy alone on inflammatory factor expression and clinical outcomes in AIS patients. A total of 200 patients were randomized 1:1 to either the experimental group (HUK + standard care) or the control group (standard care alone). Treatment was initiated within 48 hours of stroke onset and administered for 7 consecutive days. Patients were followed for a total of 90 days, including screening, treatment, and follow-up phases. Discussion: This study aims to assess changes in key inflammatory markers—including C-reactive protein (CRP), interleukin-6 (IL-6), homocysteine (HCY), and neuron-specific enolase (NSE)—following early administration of HUK. Additionally, the study will explore correlations between these biomarkers and functional outcomes to evaluate the therapeutic efficacy and safety of HUK during the acute phase of AIS. Trial Registration: ClinicalTrials.gov Identifier: NCT06696703. Registered on 16 November 2024.