Cerebral InfarctionMAISKFENCT02806128

The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship

A study testing Human Urinary Kallidinogenase for Injection in people with Cerebral Infarction, run by Huisheng Chen at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Cerebral Infarction
What is being tested?: Human Urinary Kallidinogenase for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: Nov 2016to Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

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

Age 18 to 80 years old;
First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae (mRS = 0-2);
Acute anterior circulation cerebral infarction with large artery atherosclerotic etiology;
Ability to randomize within 48 h of time last known free of new ischemic symptoms.
National Institute of Health stroke scale(NIHSS) ranges from 7 to 22;
signed written informed consent.

Who cannot join

Cerebral CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
Transient ischemic attack;
Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8;
Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time (according to its instruction), or need to be treated with ACEI;
Past or present suffering from hemorrhagic tendency of the disease;
The investigator in consideration of the other condition that the patients doesn't fit to participate in this clinical study.

Trial locations and contacts

1 site in 1 country.

Huisheng Chen contact

zhonghe Zhou contact

China1 site, 1 recruiting

General hospital of shenyang military region
Shenyang, Liaoning, 110840
Hou Xiaowen, Master, 862428897511 ext. 15840240196, sophia_hxw@163.com
Recruiting

Other trials in China

About this study

Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.

Conditions: Cerebral Infarction
Being tested: Human Urinary Kallidinogenase for Injection
Keywords: cerebral infarction, kallikrein, KLK
Medical subject headings: Cerebral Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human Urinary Kallidinogenase for InjectionDrug
Also called KLK
Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time

Study groups in NCT02806128
Study group	Role	What they receive
Treatment group	Experimental	Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days . Patients need to complete laboratory tests within a specified time. Receives: Drug: Human Urinary Kallidinogenase for Injection
Control group	Experimental	Injection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days . Patients need to complete laboratory tests within a specified time. Receives: Drug: Human Urinary Kallidinogenase for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

the decrease of National Institute of Health stroke scale(NIHSS)
Measured: 14 Days

Secondary outcomes (4)

the Barthel Index
Measured: 90 Days
the Modified Rankin Scale
Measured: 90 Days
change of the National Institute of Health stroke scale
Measured: 8 Days
the composite of ischemic vascular events
ischemic stroke, MI, or ischemic vascular death
Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Dec 2018

First posted20 Jun 2016 (estimated)
Study startNov 2016
Primary completionDec 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cerebral InfarctionStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02806128
Sponsor's protocol ID: MAISKFE1.0
Acronym: MAISKFE
Status last verified: Aug 2016
First submitted: 10 Jun 2016
Last updated: 6 Jan 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: After the completion of clinical trials ，Through the article published and upload data 。

Publications

Xia CF, Yin H, Borlongan CV, Chao L, Chao J. Kallikrein gene transfer protects against ischemic stroke by promoting glial cell migration and inhibiting apoptosis. Hypertension. 2004 Feb;43(2):452-9. doi: 10.1161/01.HYP.0000110905.29389.e5. Epub 2003 Dec 29.
PubMed 14698996
Xia CF, Smith RS Jr, Shen B, Yang ZR, Borlongan CV, Chao L, Chao J. Postischemic brain injury is exacerbated in mice lacking the kinin B2 receptor. Hypertension. 2006 Apr;47(4):752-61. doi: 10.1161/01.HYP.0000214867.35632.0e. Epub 2006 Mar 13.
PubMed 16534002
Xia CF, Yin H, Yao YY, Borlongan CV, Chao L, Chao J. Kallikrein protects against ischemic stroke by inhibiting apoptosis and inflammation and promoting angiogenesis and neurogenesis. Hum Gene Ther. 2006 Feb;17(2):206-19. doi: 10.1089/hum.2006.17.206.
PubMed 16454654
Chen ZB, Huang DQ, Niu FN, Zhang X, Li EG, Xu Y. Human urinary kallidinogenase suppresses cerebral inflammation in experimental stroke and downregulates nuclear factor-kappaB. J Cereb Blood Flow Metab. 2010 Jul;30(7):1356-65. doi: 10.1038/jcbfm.2010.19. Epub 2010 Feb 24.
PubMed 20179726

Want to know more?

Huisheng Chen

86-24-28897511

chszh@aliyun.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
ClinicalTrials.gov ID: NCT02806128
Acronym / sponsor ID: MAISKFE / MAISKFE1.0
Conditions: Cerebral Infarction
Keywords: cerebral infarction, kallikrein, KLK
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Huisheng ChenUniversity, hospital or other
Study start: Nov 2016
Primary completion: Dec 2018 (estimated)
First posted: 20 Jun 2016 (estimated)
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.

Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment group	Experimental	Drug: Human Urinary Kallidinogenase for InjectionInjection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days . Patients need to complete laboratory tests within a specified time.
Control group	Experimental	Drug: Human Urinary Kallidinogenase for InjectionInjection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days . Patients need to complete laboratory tests within a specified time.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 18 to 80 years old;
First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae (mRS = 0-2);
Acute anterior circulation cerebral infarction with large artery atherosclerotic etiology;
Ability to randomize within 48 h of time last known free of new ischemic symptoms.
National Institute of Health stroke scale(NIHSS) ranges from 7 to 22;

Key exclusion criteria (6 listed)

Cerebral CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
Transient ischemic attack;
Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8;
Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time (according to its instruction), or need to be treated with ACEI;
Past or present suffering from hemorrhagic tendency of the disease;

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 Kallidinogenase for InjectionAlso: KLKPatients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time	Drug	Control group, Treatment group

Primary outcome

the decrease of National Institute of Health stroke scale(NIHSS)
Time frame: 14 Days

4 secondary outcomes

the Barthel Index
Time frame: 90 Days
the Modified Rankin Scale
Time frame: 90 Days
change of the National Institute of Health stroke scale
Time frame: 8 Days
the composite of ischemic vascular events
Time frame: 90 Days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
Background: PubMed 14698996Xia CF, Yin H, Borlongan CV, Chao L, Chao J. Kallikrein gene transfer protects against ischemic stroke by promoting glial cell migration and inhibiting apoptosis. Hypertension. 2004 Feb;43(2):452-9. doi: 10.1161/01.HYP.0000110905.29389.e5. Epub 2003 Dec 29.
Background: PubMed 16534002Xia CF, Smith RS Jr, Shen B, Yang ZR, Borlongan CV, Chao L, Chao J. Postischemic brain injury is exacerbated in mice lacking the kinin B2 receptor. Hypertension. 2006 Apr;47(4):752-61. doi: 10.1161/01.HYP.0000214867.35632.0e. Epub 2006 Mar 13.
Background: PubMed 16454654Xia CF, Yin H, Yao YY, Borlongan CV, Chao L, Chao J. Kallikrein protects against ischemic stroke by inhibiting apoptosis and inflammation and promoting angiogenesis and neurogenesis. Hum Gene Ther. 2006 Feb;17(2):206-19. doi: 10.1089/hum.2006.17.206.
Background: PubMed 20179726Chen ZB, Huang DQ, Niu FN, Zhang X, Li EG, Xu Y. Human urinary kallidinogenase suppresses cerebral inflammation in experimental stroke and downregulates nuclear factor-kappaB. J Cereb Blood Flow Metab. 2010 Jul;30(7):1356-65. doi: 10.1038/jcbfm.2010.19. Epub 2010 Feb 24.
Individual participant dataSharing planned: Yes. After the completion of clinical trials ，Through the article published and upload data 。

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Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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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. This study is not recruiting at the moment.

Huisheng Chen contact

zhonghe Zhou contact

Huisheng Chen study chair

General Hospital of Shenyang Military Region

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Human Urinary Kallidinogenase for Injection in people with Cerebral Infarction, run by Huisheng Chen 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huisheng Chen (86-24-28897511, chszh@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the decrease of National Institute of Health stroke scale(NIHSS) (time frame: 14 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 NCT02806128, which also lists 4 linked publications.

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 Jan 2017.