T Cell Dysfunction in ESRD

NCT ID: NCT04658069

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

ESRD; T-Cell Dysfunction

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

One Cohort receiving routine hemodialysis therapy without any specific interventions

all HD patients enrolled in this study

no specific interventions

Intervention Type: OTHER

no specific interventions

Interventions

no specific interventions

no specific interventions

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bo Shen, MD

Role: STUDY_DIRECTOR

Fudan University

Fangfang Xiang, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Bo Shen, MD

Role: CONTACT

Phone: +86 13564608233

Email: shen.bo@zs-hospital.sh.cn

Fangfang Xiang, MD

Role: CONTACT

Phone: +86 13816209067

Email: xiang.fangfang@zs-hospital.sh.cn

Other Identifiers

TcdiESRD

Identifier Type: -

Identifier Source: org_study_id