T Cell Dysfunction in ESRD

ESRD Clinical Trial

Official title:

T Cell Dysfunction in End-stage Renal Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04658069
• Other study ID #: TcdiESRD
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Bo Shen, MD
• Phone: +86 13564608233
• Email: shen.bo[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ESRD
• Kidney Failure, Chronic
• T-Cell Dysfunction

Intervention

Other:
• no specific interventions
no specific interventions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	mortality during the study	January 2021 to December 2023
Secondary	Cardiovascular disease	having documented congestive heart failure, coronary artery disease, peripheral arterial occlusive disease, or stroke	January 2021 to December 2023
Secondary	Infection event	having new onset of infections which requiring standard intravenous antibiotics or hospitalization	January 2021 to December 2023
Secondary	Cancer	having new discovered tumors	January 2021 to December 2023