ESRDNCT04658069
T Cell Dysfunction in ESRD
An observational study of ESRD and T-Cell Dysfunction, run by Shanghai Zhongshan Hospital.
Trial summary
Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ESRD, T-Cell Dysfunction
- What is being tested?
- no specific interventions
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * aged 18 years and older * had been on hemodialysis treatment for at least 6 months in our blood purification center
Who may be able to join
- had been on hemodialysis treatment for at least 6 months in Blood Purification Center,Zhongshan Hospital, Fudan University
Who cannot join
- underwent any kind of cardiovascular or infection event in three months
- with hematological diseases, rheumatic diseases, active malignancies
- with history of human immunodeficiency virus infection
- currently use of any immunosuppressants
- not followed-up at Zhongshan Hospital, Fudan University
Trial locations and contacts
No sites are listed yet.
About this study
Official title: T Cell Dysfunction in End-stage Renal Disease
Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. However, few studies clarified the association of T cell dysfunction and clinical outcomes. This study is aim to explore valuable markers of T cell dysfunction predicting bad clinical outcomes including death, cardiovascular disease, infection and tumor. Hopefully, these finding will provide foundation for further mechanism research and better therapeutic options for ESRD patients in the future.
Read the detailed description
Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. Recent evidence suggests uremia-related immune changes resemble to aging immune system, increasing immunological age of T cells by 20-30 years. As compared to an age-matched healthy control, ESRD patients present a lower thymic output of naïve T cells, a decline in the T-cell telomere length and an increase in the differentiation status towards the terminal differentiated memory phenotype with a large number of CD28-negative T cells. More importantly, these changes are strongly associated with a history of cardiovascular diseases and the occurrence of severe infectious episodes in this population, supporting the idea that T cell dysfunction is a critical feature in this population and will impact clinical outcomes profoundly. This study prospectively researched the predictive value of T cell dysfunction for all-cause mortality and clinical complication in hemodialysis (HD) patients.
- Conditions
- ESRD, T-Cell Dysfunction
- Being tested
- no specific interventions
- Keywords
- T cell dysfunction, end-stage renal disease, clinical outcome
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no specific interventionsOther
no specific interventions
| Study group | Role | What they receive |
|---|---|---|
| One Cohort receiving routine hemodialysis therapy without any specific interventions | all HD patients enrolled in this study Receives: Other: no specific interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
mortality during the study
Measured: January 2021 to December 2023
Secondary outcomes (3)
Cardiovascular disease
having documented congestive heart failure, coronary artery disease, peripheral arterial occlusive disease, or stroke
Measured: January 2021 to December 2023
Infection event
having new onset of infections which requiring standard intravenous antibiotics or hospitalization
Measured: January 2021 to December 2023
Cancer
having new discovered tumors
Measured: January 2021 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bo Shen, MD, Study director, Fudan UniversityFangfang Xiang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658069
- Sponsor's protocol ID
- TcdiESRD
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 8 Dec 2020
- Results posted
- 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 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Cell Dysfunction in End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT04658069
- Acronym / sponsor ID
- TcdiESRD
- Conditions
- ESRD, T-Cell Dysfunction
- Keywords
- T cell dysfunction, end-stage renal disease, clinical outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Dec 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.
Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. However, few studies clarified the association of T cell dysfunction and clinical outcomes. This study is aim to explore valuable markers of T cell dysfunction predicting bad clinical outcomes including death, cardiovascular disease, infection and tumor. Hopefully, these finding will provide foundation for further mechanism research and better therapeutic options for ESRD patients in the future.
Detailed description
Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. Recent evidence suggests uremia-related immune changes resemble to aging immune system, increasing immunological age of T cells by 20-30 years. As compared to an age-matched healthy control, ESRD patients present a lower thymic output of naïve T cells, a decline in the T-cell telomere length and an increase in the differentiation status towards the terminal differentiated memory phenotype with a large number of CD28-negative T cells. More importantly, these changes are strongly associated with a history of cardiovascular diseases and the occurrence of severe infectious episodes in this population, supporting the idea that T cell dysfunction is a critical feature in this population and will impact clinical outcomes profoundly. This study prospectively researched the predictive value of T cell dysfunction for all-cause mortality and clinical complication in hemodialysis (HD) patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Cohort receiving routine hemodialysis therapy without any specific interventions | – | Other: no specific interventionsall HD patients enrolled in this study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * aged 18 years and older * had been on hemodialysis treatment for at least 6 months in our blood purification center
Key inclusion criteria (1 listed)
- had been on hemodialysis treatment for at least 6 months in Blood Purification Center,Zhongshan Hospital, Fudan University
Key exclusion criteria (5 listed)
- underwent any kind of cardiovascular or infection event in three months
- with hematological diseases, rheumatic diseases, active malignancies
- with history of human immunodeficiency virus infection
- currently use of any immunosuppressants
- not followed-up at Zhongshan Hospital, Fudan University
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 |
|---|---|---|
| no specific interventionsno specific interventions | Other | One Cohort receiving routine hemodialysis therapy without any specific interventions |
Primary outcome
Death
Time frame: January 2021 to December 2023
mortality during the study
3 secondary outcomes
Cardiovascular disease
Time frame: January 2021 to December 2023
Infection event
Time frame: January 2021 to December 2023
Cancer
Time frame: January 2021 to December 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 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.
Bo Shen, MD study director
Fudan University
Fangfang Xiang, MD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD and T-Cell Dysfunction, run by Shanghai Zhongshan Hospital.
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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Bo Shen, MD (+86 13564608233, shen.bo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: January 2021 to December 2023). 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 8 Dec 2020.