Clinical trial NCT04658069: T Cell Dysfunction in ESRD
Official title: T Cell Dysfunction in End-stage Renal Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ESRD
T-Cell Dysfunction
Keywords: T cell dysfunction
end-stage renal disease
clinical outcome
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * aged 18 years and older
* had been on hemodialysis treatment for at least 6 months in our blood purification center

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death
timeFrame: January 2021 to December 2023
Secondary outcomes:
measure: Cardiovascular disease
timeFrame: January 2021 to December 2023
measure: Infection event
timeFrame: January 2021 to December 2023
measure: Cancer
timeFrame: January 2021 to December 2023
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Bo Shen, MD
role: STUDY_DIRECTOR
affiliation: Fudan University
name: Fangfang Xiang, MD
role: PRINCIPAL_INVESTIGATOR
References: