- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600219
The Effect of Tyrosine Kinase Receptor Axl on Dialysis Prognosis in Chronic Hemodialysis Patients
November 1, 2020 updated by: Ai Peng
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
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200272
- Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
End-stage renal disease patients undergoing hemodialysis treatment
Description
Inclusion Criteria:
- hemodialysis for more than 6 months
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
death
Time Frame: 3 years
|
death
|
3 years
|
|
dialysis complication
Time Frame: 3 years
|
vascular access failure, stroke, acute coronary syndrome, heart failure
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ai Peng, MD,PhD, Shanghai 10th People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
October 21, 2020
First Submitted That Met QC Criteria
October 21, 2020
First Posted (Actual)
October 23, 2020
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
November 1, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AHD2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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