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Can a kidney protein drug boost stroke recovery after clot removal?

NCT ID NCT06848894

NEW Symptom relief Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether human urinary kallidinogenase, a protein-based drug, can improve recovery in adults who have had an acute ischemic stroke and received standard reperfusion treatment such as clot-busting drugs or clot-removal procedures. The trial enrolls about 1,200 patients and compares the drug plus standard care against a placebo plus standard care. The main goal is to see how many patients achieve a good functional outcome, meaning they can live independently with no or mild disability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human urinary kallidinogenase, a protein-based drug given by infusion
What this could lead to
If it works, this could offer an added treatment for stroke patients already receiving standard clot-busting therapy, potentially improving their chances of living independently.
What could go wrong
The trial is large but the drug's benefit is uncertain; it may not improve outcomes beyond standard care, and any added treatment carries risks of bleeding or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,204 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years. 2. Having anterior circulation AIS within 24 hours of onset. 3. The NIHSS score at enrollment is 4 to 25. 4. Receiving intravenous recombinant tissue plasminogen activator (rt-PA) or TNK-tPA, or endovascular treatment including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment. 5. Being independent in daily activities (mRS ≤1) before onset. 6. Patients or their legal representatives are able and willing to sign informed consent forms. Exclusion Criteria: 1. Having an Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6 or less confirmed by preoperational computed tomography scan. 2. Being already treated with HUK or any drugs containing HUK after onset. 3. Having an allergy history of HUK or drugs containing HUK, or other drugs and food. 4. Having a history of coagulation dysfunction, systemic bleeding, or thrombocytopenia; having hemorrhagic diseases at the time of enrollment, including cerebral hemorrhage, subarachnoid hemorrhage, epidural or subdural hematoma, gingival bleeding, gastrointestinal bleeding, dermal ecchymosis, etc; taking anticoagulants including warfarin, rivaroxaban, etc.; or taking heparin within 48 hours after stroke onset. 5. Taking angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs regularly within one week before enrollment, including captopril, enalapril, benazepril, etc. 6. Having chronic liver disease or liver dysfunction, with elevated ALT/AST (\>3.0×ULN ); or having kidney dysfunction or receiving dialysis, with elevated serum creatinine (\>2.0×ULN). 7. Having severe cardiopulmonary disease that are deemed unsuitable for the study by the investigators. 8. Having contraindications for intravenous thrombolysis or endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment. 9. Having lethal diseases with a life expectancy \< 3 months. 10. Being pregnant or lactating; or women of child-bearing age not taking effective contraception, or having no negative pregnancy test record. 11. Being unable to complete the study due to mental illness, cognitive or emotional disorder, physical condition, geographical factors, etc. 12. Participating in another clinical trial currently. 13. Other conditions that investigators consider he/she is not appropriate to participate in this study.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.