Hemodialysis ComplicationNCT04600219
The Effect of Tyrosine Kinase Receptor Axl on Dialysis Prognosis in Chronic Hemodialysis Patients
An observational study of Hemodialysis Complication, run by Ai Peng at 1 site in China.
Trial summary
The purpose of this study is to evaluate whether tyrosine kinase receptor Axl affects the dialysis prognosis in chronic hemodialysis patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodialysis Complication
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2021
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End-stage renal disease patients undergoing hemodialysis treatment
Who may be able to join
- hemodialysis for more than 6 months
Who cannot join
- patients who received warfarin therapy;
- patients with chronic infectious disease or acute infection;
- patients with hemodialysis inadequacy;
- the age of patients is older than 65 years or younger than 18 years.
- patients who can not sign an informed consent or disagree to follow up
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200272
About this study
Official title: The Effect of Tyrosine Kinase Receptor Axl on Dialysis Prognosis in Chronic Hemodialysis Patients: a Cohort Study
The purpose of this study is to evaluate whether tyrosine kinase receptor Axl affects the dialysis prognosis in chronic hemodialysis patients
Read the detailed description
It is reported that hemodialysis (HD) patients often develop chronic systemic inflammatoion, and increased inflammatory activity is associated with vascular access failure, cardiovascular disease and death in HD patients. The interaction of Axl and its ligand Gas6 plays an important role in modulating immune response, inhabiting toll-like receptor (TLR) signaling and suppressing inflammatory cytokines production. Thus, we want to investigate the relationship between tyrosine kinase receptor Axl and the dialysis prognosis in HD patients in three-years follow-up.
- Conditions
- Hemodialysis Complication
- Keywords
- hemodialysis, Axl, prognosis
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death
Measured: 3 years
dialysis complication
vascular access failure, stroke, acute coronary syndrome, heart failure
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Jan 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ai Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ai Peng, Shanghai 10th People's Hospital
- Investigators
- Ai Peng, MD,PhD, Study director, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600219
- Sponsor's protocol ID
- AHD2020
- Status last verified
- Nov 2020
- First submitted
- 21 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tyrosine Kinase Receptor Axl on Dialysis Prognosis in Chronic Hemodialysis Patients: a Cohort Study
- ClinicalTrials.gov ID
- NCT04600219
- Acronym / sponsor ID
- AHD2020
- Conditions
- Hemodialysis Complication
- Keywords
- hemodialysis, Axl, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ai PengUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 23 Oct 2020 (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 purpose of this study is to evaluate whether tyrosine kinase receptor Axl affects the dialysis prognosis in chronic hemodialysis patients
Detailed description
It is reported that hemodialysis (HD) patients often develop chronic systemic inflammatoion, and increased inflammatory activity is associated with vascular access failure, cardiovascular disease and death in HD patients. The interaction of Axl and its ligand Gas6 plays an important role in modulating immune response, inhabiting toll-like receptor (TLR) signaling and suppressing inflammatory cytokines production. Thus, we want to investigate the relationship between tyrosine kinase receptor Axl and the dialysis prognosis in HD patients in three-years follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage renal disease patients undergoing hemodialysis treatment
Key inclusion criteria (1 listed)
- hemodialysis for more than 6 months
Key exclusion criteria (5 listed)
- patients who received warfarin therapy;
- patients with chronic infectious disease or acute infection;
- patients with hemodialysis inadequacy;
- the age of patients is older than 65 years or younger than 18 years.
- patients who can not sign an informed consent or disagree to follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death
Time frame: 3 years
death
dialysis complication
Time frame: 3 years
vascular access failure, stroke, acute coronary syndrome, heart failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- 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. This study is not recruiting at the moment.
Ai Peng, MD,PhD study director
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Complication, run by Ai Peng 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 1 inclusion and 5 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 3 Nov 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.