NCT07283159

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
20mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

December 2, 2025

Last Update Submit

January 22, 2026

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • 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

    90±7 days

Secondary Outcomes (11)

  • proportion of modified Rankin Scale (mRS) 0-2

    90±7 days

  • ordinal distribution of modified Rankin Scale (mRS)

    90±7 days

  • change in National Institute of Health stroke scale (NIHSS) score

    24 (-6/+12) hours

  • change in National Institute of Health stroke scale (NIHSS) score

    10±2 days

  • occurrence of early neurological improvement (ENI)

    24 (-6/+12) hours

  • +6 more secondary outcomes

Study Arms (2)

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

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

Drug: Human Urinary Kallidinogenase

Interventions

Human Urinary KallidinogenaseDRUG

Human Urinary Kallidinogenase is administered intravenously, with 0.15 PNA units dissolved in 100 ml of normal saline.

Control groupexperimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

January 20, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

CN(1)