Acute Ischemic StrokeNCT06132880
Effects of Human Urinary Kallidinogenase on Early Improvement and Functional Outcomes in Acute Ischemic Stroke (TK-SPEED)
A study testing Human Urinary Kallidinogenase and Clinical Routine Treatment in people with Acute Ischemic Stroke and Functional Outcomes, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
The primary purpose of this trial is to evaluate the effects of Human Urinary Kallidinogenase on improvement of neurological outcome, and early cerebral perfusion in acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Functional Outcomes
- What is being tested?
- Human Urinary Kallidinogenase and Clinical Routine Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age;
- Diagnosis of anterior circulation acute ischemic stroke;
- Within 48 hours of symptoms onset;
- modified Rankin Scale (mRS) score≤1 before this event;
- 5≤NIHSS≤20 at screening;
- The availability of informed consent.
Who cannot join
- Patients who have already or are going to receive intravenous thrombolytic/mechanical thrombectomy therapy after onset;
- Patients with severe consciousness disorder, NIHSS 1a consciousness level score≥2;
- Patients with limited limb mobility such as fractures and claudication upon admission;
- Patients who have already or are going to receive Edaravone injection, Edaravone and DeKanol concentrated solution for injection, Butylphthalide and sodium chloride injection or Butylphthalide soft capsules after onset;
- Hypotensive (systolic blood pressure <90 mmHg or diastolic blood pressure<60 mmHg) on admission;
- History of severe drug or food allergy, allergy or intolerance to Human Urinary Kallidinogenase;
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- Patients who have been on angiotensin-converting enzyme inhibitor (ACEI) drugs and within 5 half-lives (according to the specific drug instructions) before initiate Human Urinary Kallidinogenase treatment;
- Pregnancy, lactation, or planned pregnancy within 90 days;
- Patients with severe renal failure or impairment (eGFR<30ml/min/1.73m2) at screening;
- Severe hepatic dysfunction, elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (more than 2.5 times of upper limit of normal value), other liver diseases such as acute and chronic hepatitis, cirrhosis, etc;
- Patients with heart failure (NYHA class III or IV), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, and degree II and III cardiac conduction obstruction within 6 months prior to randomization;
- Heavy drinking in the three months before screening, drinking≥5 standard drinks per day (1 standard drink is equivalent to120ml wine, 360ml beer or 45ml liquor);
- Drug Abuse or addiction in the past year;
- Patients with a malignant tumor, severe systemic diseases, or estimated survival time <90 days;
- Patients with severe mental disorders or dementia unable to complete the informed consent and follow-up;
- Have participated in another interventional clinical study within 30 days before randomization or are participating in another interventional clinical study;
- Other cases unsuitable for this clinical study assessed by researcher.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Human Urinary Kallidinogenase on Early Improvement and Functional Outcomes in Acute Ischemic Stroke: a Multicenter, Randomized, Open Label, Blinded-endpoint, Controlled Study (TK-SPEED)
The primary purpose of this trial is to evaluate the effects of Human Urinary Kallidinogenase on improvement of neurological outcome, and early cerebral perfusion in acute ischemic stroke.
Read the detailed description
This is a multicentre, randomized, open label, blinded-endpoint trial that aims to investigate the effects of Human Urinary Kallidinogenase treatment on neurological outcomes, early cerebral perfusion in patients with acute anterior circulation ischemic stroke. Patients in intervention group will be given 0.15 peptide nucleic acids (PNA) Human Urinary Kallidinogenase concentrated solution for intravenous injection once a day for 10 days continuously, and those in the control group will be given conventional therapy. Both groups of patients will be on standard stroke care. In this study, patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio after the informed consent form (ICF) was received. The total sample size will be 540. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2. Besides, the investigators aimed to use computed tomography perfusion (CTP) evaluate the differences of ischemic penumbra volume and regional cerebral blood flow (rCBF) before and after treatment between intervention group and control group.
Furthermore, this study adopts adaptive design, prospectively stating interim analyses with specified stopping rules, which allow for the possibility of the study to terminate early based on either determination of study success or of the futility to continue further enrollment.
- Conditions
- Acute Ischemic Stroke, Functional Outcomes
- Being tested
- Human Urinary Kallidinogenase, Clinical Routine Treatment
- Keywords
- Acute Ischemic Stroke, Functional Outcomes, Early cerebral perfusion, 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
Intravenous injections of urinary kallidinogenase (0.15 peptide nucleic acids (PNA) in 0.9% NaCl) intravenous drip QD for 10 days.
Clinical Routine TreatmentOther
Conventional therapy of acute ischemic stroke after based on Chinese guidelines
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intravenous injections of urinary kallidinogenase (0.15 peptide nucleic acids (PNA) in 0.9% NaCl) intravenous drip quaquedie (QD) for 10 days. Receives: Drug: Human Urinary Kallidinogenase; Other: Clinical Routine Treatment |
| Control group | Other | Conventional therapy of acute ischemic stroke after based on Chinese guidelines. Receives: Other: Clinical Routine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90
The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90. mRS scores range from 0 to 6. 0=no symptoms,1 = symptoms without clinically significant disability,2 = slight disability,3 = moderate disability,4 = moderately severe disability,5 = severe disability; and 6 = death.
Measured: 90 days
Secondary outcomes (6)
Change of Tmax>6s volume
Change of Tmax>6s volume on CTP from baseline to 5 days after treatment
Measured: 5 days
Change of rCBF in Tmax>6s area
Change of rCBF in Tmax>6s area on CTP from baseline to 5 days after treatment
Measured: 5 days
Ordinal distribution of modified Rankin Scale (mRS) at day 90
Ordinal distribution of modified Rankin Scale (mRS) at day 90. mRS scores range from 0 to 6. 0=no symptoms,1 = symptoms without clinically significant disability,2 = slight disability,3 = moderate disability,4 = moderately severe disability,5 = severe disability; and 6 = death.
Measured: 90 days
The proportion of patients with modified Rankin Scale (mRS) 0-1 at day 90
The proportion of patients with modified Rankin Scale (mRS) 0-1 at day 90. mRS scores range from 0 to 6. 0=no symptoms,1 = symptoms without clinically significant disability,2 = slight disability,3 = moderate disability,4 = moderately severe disability,5 = severe disability; and 6 = death.
Measured: 90 days
Change of National Institute of Health stroke Scale (NIHSS) score at day 5 after treatment.
Change of National Institute of Health stroke Scale (NIHSS) score from baseline to 5 days after treatment. NIHSS ranges from 0 to 42, a low value represents a better outcome.
Measured: 5 days
Change of National Institute of Health stroke scale (NIHSS) score at day 10 after treatment.
Change of National Institute of Health stroke scale (NIHSS) score from baseline to 10 days after treatment. NIHSS ranges from 0 to 42, a low value represents a better outcome.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start14 Dec 2023 (estimated)
- Primary completion28 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital
- Responsible party
- Sponsor
- Investigators
- Jian Wu, Study chair, Beijing Tsinghua Changgeng HospitalZunjing Liu, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132880
- Sponsor's protocol ID
- KLK-S024
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song X, Qi Z, Gao C, Wei C, Wang D, Zhao X, Hou C, Liu Z, Wu J. Effects of human urinary kallidinogenase on early neurological improvement and functional outcomes in acute ischaemic stroke (TK-SPEED): protocol for a multi-centre, randomised, open-label, blinded-endpoint controlled study. Stroke Vasc Neurol. 2026 Sep 9:svn-2026-005582. doi: 10.1136/svn-2026-005582. Online ahead of print.
PubMed 42716572
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Human Urinary Kallidinogenase on Early Improvement and Functional Outcomes in Acute Ischemic Stroke: a Multicenter, Randomized, Open Label, Blinded-endpoint, Controlled Study (TK-SPEED)
- ClinicalTrials.gov ID
- NCT06132880
- Acronym / sponsor ID
- KLK-S024
- Conditions
- Acute Ischemic Stroke, Functional Outcomes
- Keywords
- Acute Ischemic Stroke, Functional Outcomes, Early cerebral perfusion, Human Urinary Kallidinogenase
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital
- Study start
- 14 Dec 2023 (estimated)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Nov 2023 (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.
The primary purpose of this trial is to evaluate the effects of Human Urinary Kallidinogenase on improvement of neurological outcome, and early cerebral perfusion in acute ischemic stroke.
Detailed description
This is a multicentre, randomized, open label, blinded-endpoint trial that aims to investigate the effects of Human Urinary Kallidinogenase treatment on neurological outcomes, early cerebral perfusion in patients with acute anterior circulation ischemic stroke. Patients in intervention group will be given 0.15 peptide nucleic acids (PNA) Human Urinary Kallidinogenase concentrated solution for intravenous injection once a day for 10 days continuously, and those in the control group will be given conventional therapy. Both groups of patients will be on standard stroke care. In this study, patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio after the informed consent form (ICF) was received. The total sample size will be 540. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2. Besides, the investigators aimed to use computed tomography perfusion (CTP) evaluate the differences of ischemic penumbra volume and regional cerebral blood flow (rCBF) before and after treatment between intervention group and control group.
Furthermore, this study adopts adaptive design, prospectively stating interim analyses with specified stopping rules, which allow for the possibility of the study to terminate early based on either determination of study success or of the futility to continue further enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Human Urinary Kallidinogenase, Other: Clinical Routine TreatmentIntravenous injections of urinary kallidinogenase (0.15 peptide nucleic acids (PNA) in 0.9% NaCl) intravenous drip quaquedie (QD) for 10 days. |
| Control group | Other | Other: Clinical Routine TreatmentConventional therapy of acute ischemic stroke after based on Chinese guidelines. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 to 80 years of age;
- Diagnosis of anterior circulation acute ischemic stroke;
- Within 48 hours of symptoms onset;
- modified Rankin Scale (mRS) score≤1 before this event;
- 5≤NIHSS≤20 at screening;
Key exclusion criteria (17 listed)
- Patients who have already or are going to receive intravenous thrombolytic/mechanical thrombectomy therapy after onset;
- Patients with severe consciousness disorder, NIHSS 1a consciousness level score≥2;
- Patients with limited limb mobility such as fractures and claudication upon admission;
- Patients who have already or are going to receive Edaravone injection, Edaravone and DeKanol concentrated solution for injection, Butylphthalide and sodium chloride injection or Butylphthalide soft capsules after onset;
- Hypotensive (systolic blood pressure <90 mmHg or diastolic blood pressure<60 mmHg) on admission;
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 KallidinogenaseIntravenous injections of urinary kallidinogenase (0.15 peptide nucleic acids (PNA) in 0.9% NaCl) intravenous drip QD for 10 days. | Drug | Intervention group |
| Clinical Routine TreatmentConventional therapy of acute ischemic stroke after based on Chinese guidelines | Other | Control group, Intervention group |
Primary outcome
The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90
Time frame: 90 days
The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90. mRS scores range from 0 to 6. 0=no symptoms,1 = symptoms without clinically significant disability,2 = slight disability,3 = moderate disability,4 = moderately severe disability,5 = severe disability; and 6 = death.
6 secondary outcomes
Change of Tmax>6s volume
Time frame: 5 days
Change of rCBF in Tmax>6s area
Time frame: 5 days
Ordinal distribution of modified Rankin Scale (mRS) at day 90
Time frame: 90 days
The proportion of patients with modified Rankin Scale (mRS) 0-1 at day 90
Time frame: 90 days
Change of National Institute of Health stroke Scale (NIHSS) score at day 5 after treatment.
Time frame: 5 days
Change of National Institute of Health stroke scale (NIHSS) score at day 10 after treatment.
Time frame: 10 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 6 Dec 2023.
- Derived from this study: PubMed 42716572Song X, Qi Z, Gao C, Wei C, Wang D, Zhao X, Hou C, Liu Z, Wu J. Effects of human urinary kallidinogenase on early neurological improvement and functional outcomes in acute ischaemic stroke (TK-SPEED): protocol for a multi-centre, randomised, open-label, blinded-endpoint controlled study. Stroke Vasc Neurol. 2026 Sep 9:svn-2026-005582. doi: 10.1136/svn-2026-005582. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Jian Wu study chair
Beijing Tsinghua Changgeng Hospital
Zunjing Liu study chair
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Human Urinary Kallidinogenase and Clinical Routine Treatment in people with Acute Ischemic Stroke and Functional Outcomes, run by Beijing Tsinghua Chang Gung Hospital.
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 6 inclusion and 17 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: opening soon, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Xiaowei Song (18810363866, sxwa01271@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06132880, which also lists 1 linked publication.
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 6 Dec 2023.