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Clinical Trial
. 2021 Dec;27(12):1493-1503.
doi: 10.1111/cns.13724. Epub 2021 Sep 12.

Human urinary kallidinogenase in acute ischemic stroke: A single-arm, multicenter, phase IV study (RESK study)

Jun Ni  1 , Ming Yao  1 , Li-Hua Wang  2 , Ming Yu  3 , Run-Hui Li  4 , Li-Hong Zhao  5 , Jia-Chun Wang  6 , Yin-Zhou Wang  7 , Xin Wang  8 , Hai-Qing Song  9 , Ben-Yan Luo  10 , Jia-Wei Wang  11 , Yi-Ning Huang  12 , Li-Ying Cui  1 ; RESK Investigators
Collaborators, Affiliations
Clinical Trial

Human urinary kallidinogenase in acute ischemic stroke: A single-arm, multicenter, phase IV study (RESK study)

Jun Ni et al. CNS Neurosci Ther. 2021 Dec.

Abstract

Aims: Human urinary kallidinogenase (HUK) has shown favorable efficacies in acute ischemic stroke (AIS) treatment. We sought confirmation of the safety and efficacy of HUK for AIS in a large population.

Methods: RESK study enrolled patients with AIS of anterior circulation to receive HUK infusion. The primary endpoint was the incidence of treatment-emergent adverse events (AEs). Secondary endpoints assessed neurological and functional improvements and stroke recurrent rate.

Results: Of 1206 eligible patients, 1202 patients received at least one dose of HUK infusion and 983 (81.5%) completed the study. The incidence of treatment-emergent AEs and serious AEs were 55.99% and 2.41%, respectively. Pre-specified AEs of special interest occurred in 21.71% of patients, but the majority were mild and unrelated to therapy. Hypertension, age, treatment time, and drug combination were identified to be associated with drug-related blood pressure reduction. Neurological and functional evaluations revealed favorable outcomes from baseline to post-treatment assessment. The cumulative recurrence rate of stroke was 2.50% during the 90-day assessment.

Conclusion: HUK had an acceptable safety and tolerability profile in AIS patients. Besides, HUK demonstrated the neurological and functional improvements in AIS, further confirming its clinical efficacy in a real-world large population.

Keywords: acute ischemic stroke; clinical trial; efficacy; human urinary kallidinogenase; safety.

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Conflict of interest statement

All authors report no conflicts.

Figures

FIGURE 1
FIGURE 1
Study profile
FIGURE 2
FIGURE 2
Patient flow diagram
FIGURE 3
FIGURE 3
Forest plot of the logistic regression analysis. (A) Univariate analysis; (B) Multivariate analysis. * The “first onset” included the patients who were admitted to hospital admission for a first‐onset ischemic stroke but had no previous history of cerebral infarction. †Cerebral infarction refers to the previous history of disease, including patients who had a cerebral infarction previously
FIGURE 4
FIGURE 4
Distribution of mRS score at baseline and 90 days in the FAS and PPS population. Data were expressed as number (%). * Death was assigned a mRS score of 6 points. FAS, full analysis set; mRS, modified Rankin Scale; PPS, per‐protocol set
See this image and copyright information in PMC

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