Re-evaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK): Protocol for an Open-Label, Single-Arm, Multicenter Phase IV Trial for the Treatment of Acute Ischemic Stroke in Chinese Patients

Ni, Jun; Qu, Jiazhi; Yao, Ming; Zhang, Zhijun; Xu, Zhong

doi:10.1007/s12975-017-0527-5

Cited by 12 publications

(9 citation statements)

References 13 publications

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“…Studies have found that HUK can improve blood glucose utilization, promote glucose transfer, and improve insulin sensitivity. [40] This is likely to support the beneficial action of urinary kallidinogenase. Abnormal glucose metabolism is common in stroke patients and is significantly associated with the occurrence and damage of cerebral infarction.…”

Section: Discussionmentioning

confidence: 86%

Effects of Urinary Kallidinogenase on NIHSS score, mRS score, and fasting glucose levels in acute ischemic stroke patients with abnormal glucose metabolism

et al. 2019

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Urinary kallidinogenase may assist recovery acute ischemic stroke. This study evaluated the effect of urinary kallidinogenase on National Institute of Health Stroke Scale (NIHSS) score, modified Rankin scale (mRS) score, and fasting glucose levels in patients with acute ischemic stroke (AIS) combined with diabetes mellitus and impaired fasting glucose.Patients with AIS and abnormal glucose metabolism were enrolled in this prospective cohort study and divided into 2 groups. The human urinary kallidinogenase (HUK) group were treated with urinary kallidinogenase and standard treatment; the control group received standard treatment. NIHSS scores, mRS scores, and fasting blood glucose were evaluated and compared.A total of 113 patients were included: 58 in the HUK group and 55 in the control group. NIHSS scores decreased with treatment in both groups (time effect P < .05), but were lower in the HUK group (main effect P = .026). The mRS score decreased in both groups from 10 until 90 days after treatment (time effect P < .05); the 2 groups were similar (main effect, P = .130). Blood glucose levels decreased in both groups 10 days after treatment (time effect, P < .05), but there was no significant treatment effect (main effect, P = .635). Multivariate analysis showed blood uric acid >420 μmol/L (odds ratio [OR]: 0.053, 95% confidence interval [CI]: 0.008–0.350; P = .002) and application of HUK (OR: 0.217, 95% CI: 0.049–0.954; P = .043) were associated with 90% NIHSS recovery. Baseline NIHSS score was independently associated with poor curative effect.Urinary kallidinogenase with conventional therapy significantly improved NIHSS scores in patients with AIS. Urinary kallidinogenase also showed a trend toward lower fasting blood glucose levels, although the level did not reach significance.

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Section: Discussionmentioning

confidence: 86%

Effects of Urinary Kallidinogenase on NIHSS score, mRS score, and fasting glucose levels in acute ischemic stroke patients with abnormal glucose metabolism

et al. 2019

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“…The research included 24 trials involving 2433 patients, in which 15 trials reported that the common adverse event was transient hypotension, and there was no difference between the treatment group and control group on non-fatal intracerebral hemorrhage. A multi-center, open label, single group study has been designed and registered in ClinicalTrials.gov to reevaluate the safety and efficacy of HUK on acute ischemic stroke, and the study expects to enroll 60 sites and 2186 subjects ( 25 ).…”

Section: Results From Clinical Trialsmentioning

confidence: 99%

Therapeutic Values of Human Urinary Kallidinogenase on Cerebrovascular Diseases

Wei

Lyu²,

Yang

et al. 2018

Front. Neurol.

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The term “tissue kallikrein” is used to describe a group of serine proteases shared considerable sequence homology and colocalize in the same chromosomal locus 19q13. 2–q13.4. It has been widely discovered in various tissues and has been proved to be involved in kinds of pathophysiological processes, such as inhibiting oxidative stress, inflammation, apoptosis, fibrosis and promoting angiogenesis, and neurogenesis. Human Urinary Kallidinogenase (HUK) extracted from human urine is a member of tissue kallikrein which could convert kininogen to kinin and hence improve the plasma kinin level. Medical value of HUK has been widely investigated in China, especially on acute ischemic stroke. In this review, we will summarize the therapeutic values of Human Urinary Kallidinogenase on acute ischemic stroke and its potential mechanisms.

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“…Approximately 400,000 AIS patients have been treated with uKLK1 over the past 10 years. 88 Extensive clinical literature documents the apparent efficacy of uKLK1 based on clinical research conducted in China. The regulatory approval in China was based, at least partly, upon a multicenter, randomized, double-blind, placebo-controlled trial of 446 AIS patients.…”

Section: Therapeutic Action Of Klk1 Treatment In Human Aismentioning

confidence: 99%

Human tissue kallikrein in the treatment of acute ischemic stroke

Alexander-Curtis

Pauls

Chao

et al. 2019

Ther Adv Neurol Disord

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Acute ischemic stroke (AIS) remains a major cause of death and disability throughout the world. The most severe form of stroke results from large vessel occlusion of the major branches of the Circle of Willis. The treatment strategies currently available in western countries for large vessel occlusion involve rapid restoration of blood flow through removal of the offending blood clot using mechanical or pharmacological means (e.g. tissue plasma activator; tPA). This review assesses prospects for a novel pharmacological approach to enhance the availability of the natural enzyme tissue kallikrein (KLK1), an important regulator of local blood flow. KLK1 is responsible for the generation of kinins (bradykinin and kallidin), which promote local vasodilation and long-term vascularization. Moreover, KLK1 has been used clinically as a direct treatment for multiple diseases associated with impaired local blood flow including AIS. A form of human KLK1 isolated from human urine is approved in the People’s Republic of China for subacute treatment of AIS. Here we review the rationale for using KLK1 as an additional pharmacological treatment for AIS by providing the biochemical mechanism as well as the human clinical data that support this approach.

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Re-evaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK): Protocol for an Open-Label, Single-Arm, Multicenter Phase IV Trial for the Treatment of Acute Ischemic Stroke in Chinese Patients

Abstract: The study has registered on ClinicalTrials.gov (NCT02562183).

Cited by 12 publications

References 13 publications

Effects of Urinary Kallidinogenase on NIHSS score, mRS score, and fasting glucose levels in acute ischemic stroke patients with abnormal glucose metabolism

Effects of Urinary Kallidinogenase on NIHSS score, mRS score, and fasting glucose levels in acute ischemic stroke patients with abnormal glucose metabolism

Therapeutic Values of Human Urinary Kallidinogenase on Cerebrovascular Diseases

Human tissue kallikrein in the treatment of acute ischemic stroke

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