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RECRUITINGPHASE2

Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS): a Prospective, Randomized, Double Blinded and Multi-center Study

NCT07283159•General Hospital of Shenyang Military Region

View on ClinicalTrials.gov

Summary

Human urinary kallidinogenase (HUK) is a tissue kallikrein extracted from human urine. Under certain conditions, tissue kallikrein can convert kininogen into kallidin and kinins, thereby promoting vascular endothelial function, and exerting anti-inflammatory and antioxidant effects. Preclinical and clinical studies have demonstrated that HUK can salvage the ischemic penumbra and significantly promote the establishment of collateral circulation. Existing research suggests that the combination of HUK with intravenous alteplase significantly improves neurological function in patients with acute ischemic stroke (AIS) without increasing the risk of hemorrhage. However, whether its combination with tenecteplase can further enhance neurological recovery in patients remains unreported. Based on the above discussion, this study aims to investigate the efficacy and safety of combining tenecteplase with HUK in the treatment of AIS.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 year;
•Acute ischemic stroke confirmed by neuroimaging;
•The time from last known well to treatment is within 4.5 hours;
•NIHSS ≥ 6 at randomization;
•Received intravenous tenecteplase (0.25mg/kg);
•First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
•Signed informed consent.

Exclusion Criteria

•Planed for endovascular treatment;
•Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode；
•Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection；
•Pregnancy；
•Allergy to the investigational drug(s)；
•Comorbidity with other serious diseases;
•Participating in other clinical trials within 3 months;
•Patients not suitable for the study considered by researcher.

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China

Key Dates

Start Date

January 20, 2026

Primary Completion Date

September 30, 2027

Completion Date

December 30, 2027

Last Updated

January 23, 2026

Enrollment

200

ESTIMATED participants

Conditions

Ischemic Stroke

Interventions

Human Urinary Kallidinogenase

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

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