T Cell Dysfunction in ESRD

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04658069
Collaborator
(none)
400
35.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
T Cell Dysfunction in End-stage Renal Disease
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Death [January 2021 to December 2023]

    mortality during the study

Secondary Outcome Measures

  1. Cardiovascular disease [January 2021 to December 2023]

    having documented congestive heart failure, coronary artery disease, peripheral arterial occlusive disease, or stroke

  2. Infection event [January 2021 to December 2023]

    having new onset of infections which requiring standard intravenous antibiotics or hospitalization

  3. Cancer [January 2021 to December 2023]

    having new discovered tumors

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

  • Study Director: Bo Shen, MD, Fudan University
  • Principal Investigator: Fangfang Xiang, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT04658069
Other Study ID Numbers:
  • TcdiESRD
First Posted:
Dec 8, 2020
Last Update Posted:
Dec 8, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Zhongshan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2020