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Tests human urinary kallidinogenase in acute ischemic stroke patients

Tests whether early kallidinogenase treatment changes inflammation in adults with acute stroke.

Key facts

Who runs it
First Affiliated Hospital of Harbin Medical University
Where
Harbin, ChinaSee the site
Trial code
Registry title
Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke (KIF-AIS)
Status
Recruiting
People taking part
200 people, planned
Started
1 Jan 2024
Planned end
1 Dec 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Human urinary kininogenase(HUK)
  • Placebo
Record updated
20 November 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a sudden stroke caused by a blocked brain artery (acute ischemic stroke), with mild to moderate-to-severe symptoms.

Age
18 years or older
Sex
Women and men can join
Disease stage
Acute ischemic stroke. First stroke, or an earlier stroke without severe lasting problems (premorbid mRS ≤2). Stroke severity score (NIHSS) between 3 and 25.
Earlier treatment
People who took ACEI drugs before the trial, for less than 5 half-lives of the drug, cannot join. ACEI drugs are also not allowed during the study.

Main reasons for not taking part

  • Bleeding in the brain or other bleeding disease in the acute phase
  • Earlier allergy or intolerance to injectable HUK
  • Stent surgery after the stroke began, or planned interventional treatment
  • Pregnancy, breastfeeding or planned pregnancy
  • Life expectancy under 3 months, or taking part in other clinical research

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018
  • First clinical onset or previous presence of cerebral infarction without severe sequelae（Premorbid mRS ≤2）
  • Age≥18 years, male or female
  • 3≤Baseline NIHSS≤25
  • Written informed consent obtained from the patient or legally responsible person

Who cannot take part

  • Previously allergic or intolerant to injectable HUK；
  • Used ACEI drugs prior to medication and less than 5 half-lives of the drug (according to the specific drug instructions) or received ACEI drugs during the study period
  • Stent surgery after the AIS onset or planned interventional therapy
  • Other causes of AIS (such as dissection, vasculitis, pre-thrombotic lesions, drug abuse)
  • Cerebral hemorrhage and the acute phase of other hemorrhagic diseases；
  • Pregnancy, lactation or planned pregnancy；
  • Life expectancy of less than 3months or inability to complete the study for other reasons；
  • Unwilling to be followed up or poor compliance；
  • Current participation in other clinical research

Where in China

  • Zhongling ZhangHarbin, ChinaContact: Zhongling ZhangTaking people

About the trial

What the trial wants to find out

The goal of this clinical trial is to explore the changes in the expression levels of inflammatory factors before and after the early treatment of Human Urinary Kallidinogen (HUK) in the acute ischemic stroke. It will also learn about the correlation between inflammatory factors and AIS prognosis, in order to clarify the efficacy and safety of Urinary Kallidinogen in the acute phase of AIS.

The 2 groups in the trial

  • Human Urinary Kallidinogenase for injection (HUK)Treatment being tested

    Patients in this arm will be given urinary kallidinogenase for injection，0.15 peptide nucleic acids (PNA)， once a day for 7days plus routine clinical treatment

    Treatment: Human urinary kininogenase(HUK)

  • sham-HUK treatmentPlacebo, for comparison

    Normal sodium chloride injection plus routine clinical treatment

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)
Plain-language title
Tests human urinary kallidinogenase in acute ischemic stroke patientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
20 November 2024