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T Cell Dysfunction in ESRD

T Cell Dysfunction in End-stage Renal Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04658069
Enrollment
400
Registered
2020-12-08
Start date
2021-01-01
Completion date
2023-12-31
Last updated
2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESRD, T-Cell Dysfunction

Keywords

T cell dysfunction, end-stage renal disease, clinical outcome

Brief 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. 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.

Interventions

no specific interventions

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* had been on hemodialysis treatment for at least 6 months in Blood Purification Center,Zhongshan Hospital, Fudan University

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
DeathJanuary 2021 to December 2023mortality during the study

Secondary

MeasureTime frameDescription
Cardiovascular diseaseJanuary 2021 to December 2023having documented congestive heart failure, coronary artery disease, peripheral arterial occlusive disease, or stroke
Infection eventJanuary 2021 to December 2023having new onset of infections which requiring standard intravenous antibiotics or hospitalization
CancerJanuary 2021 to December 2023having new discovered tumors

Contacts

Primary ContactBo Shen, MD
shen.bo@zs-hospital.sh.cn+86 13564608233
Backup ContactFangfang Xiang, MD
xiang.fangfang@zs-hospital.sh.cn+86 13816209067

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026