T Cell Dysfunction in ESRD

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ESRD; T-Cell Dysfunction
• Intervention / Treatment: Other: no specific interventions

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Fangfang Xiang, MD; Phone Number: +86 13816209067; Email: xiang.fangfang@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
One Cohort receiving routine hemodialysis therapy without any specific interventions; all HD patients enrolled in this study	Other: no specific interventions; no specific interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	mortality during the study	January 2021 to December 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular disease	having documented congestive heart failure, coronary artery disease, peripheral arterial occlusive disease, or stroke	January 2021 to December 2023
Infection event	having new onset of infections which requiring standard intravenous antibiotics or hospitalization	January 2021 to December 2023
Cancer	having new discovered tumors	January 2021 to December 2023

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Director: Bo Shen, MD, Fudan University; Principal Investigator: Fangfang Xiang, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: end-stage renal disease; clinical outcome; T cell dysfunction
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: TcdiESRD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No