Ischemic StrokePhase 2NCT07283159
Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)
A Phase 2 study testing Human Urinary Kallidinogenase in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Human Urinary Kallidinogenase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
Hui-Sheng Chen, Ph.D., +86 13352452086, chszh@aliyun.com
About this study
Official title: Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS): a Prospective, Randomized, Double Blinded and Multi-center Study
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.
- Conditions
- Ischemic Stroke
- Being tested
- Human Urinary Kallidinogenase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Urinary KallidinogenaseDrug
Human Urinary Kallidinogenase is administered intravenously, with 0.15 PNA units dissolved in 100 ml of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Urinary Kallidinogenase with 0.15 PNA units dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily Receives: Drug: Human Urinary Kallidinogenase |
| Control group | Placebo comparator | Urinary Kallidinogenase with placebo dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily Receives: Drug: Human Urinary Kallidinogenase |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Measured: 90±7 days
Secondary outcomes (11)
proportion of modified Rankin Scale (mRS) 0-2
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Measured: 90±7 days
ordinal distribution of modified Rankin Scale (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Measured: 90±7 days
change in National Institute of Health stroke scale (NIHSS) score
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Measured: 24 (-6/+12) hours
change in National Institute of Health stroke scale (NIHSS) score
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Measured: 10±2 days
occurrence of early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score
Measured: 24 (-6/+12) hours
new stroke or other vascular event(s)
Measured: 90±7 days
symptomatic intracranial hemorrhage (sICH)
sICH was defined as any evidence of bleeding on the head computed tomographic scan associated with clinically significant neurological deterioration (≥4-point increase in NIHSS score).
Measured: 24 (-6/+12) hours
major systemic bleeding events
Bleeding leading to a decrease in hemoglobin ≥ 2 g/dL or transfusion of ≥ 2 units of blood.
Measured: 24 (-6/+12) hours
any bleeding events
Including skin and mucosal bleeding, gingival bleeding, bleeding at other organ sites, and other types of hemorrhage.
Measured: 24 (-6/+12) hours
any intracranial hemorrhage
Heidelberg Bleeding Classification
Measured: 10±2 days
all-cause mortality
death from any cause
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start20 Jan 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283159
- Sponsor's protocol ID
- Y (2025) 357
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS): a Prospective, Randomized, Double Blinded and Multi-center Study
- ClinicalTrials.gov ID
- NCT07283159
- Acronym / sponsor ID
- Y (2025) 357
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Human Urinary KallidinogenaseUrinary Kallidinogenase with 0.15 PNA units dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily |
| Control group | Placebo comparator | Drug: Human Urinary KallidinogenaseUrinary Kallidinogenase with placebo dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (8 listed)
- 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)；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Urinary KallidinogenaseHuman Urinary Kallidinogenase is administered intravenously, with 0.15 PNA units dissolved in 100 ml of normal saline. | Drug | Control group, experimental group |
Primary outcome
proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
Time frame: 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
11 secondary outcomes
proportion of modified Rankin Scale (mRS) 0-2
Time frame: 90±7 days
ordinal distribution of modified Rankin Scale (mRS)
Time frame: 90±7 days
change in National Institute of Health stroke scale (NIHSS) score
Time frame: 24 (-6/+12) hours
change in National Institute of Health stroke scale (NIHSS) score
Time frame: 10±2 days
occurrence of early neurological improvement (ENI)
Time frame: 24 (-6/+12) hours
new stroke or other vascular event(s)
Time frame: 90±7 days
symptomatic intracranial hemorrhage (sICH)
Time frame: 24 (-6/+12) hours
major systemic bleeding events
Time frame: 24 (-6/+12) hours
any bleeding events
Time frame: 24 (-6/+12) hours
any intracranial hemorrhage
Time frame: 10±2 days
all-cause mortality
Time frame: 90±7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Urinary Kallidinogenase in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1) (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 4 Nov 2026.