T Cell Dysfunction in ESRD

NCT04658069 | Unknown

• 1 other identifier: TcdiESRD
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ESRD; T-Cell Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Death

  mortality during the study

  January 2021 to December 2023

Secondary Outcomes (3)

• Cardiovascular disease

  January 2021 to December 2023

• Infection event

  January 2021 to December 2023

• Cancer

  January 2021 to December 2023

Study Arms (1)

One Cohort receiving routine hemodialysis therapy without any specific interventions

all HD patients enrolled in this study

Other: no specific interventions

Interventions

no specific interventions OTHER

no specific interventions

One Cohort receiving routine hemodialysis therapy without any specific interventions

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• had been on hemodialysis treatment for at least 6 months in Blood Purification Center,Zhongshan Hospital, Fudan University

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bo Shen, MD

  Fudan University

  STUDY DIRECTOR

• Fangfang Xiang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Shen, MD

CONTACT

+86 13564608233; shen.bo@zs-hospital.sh.cn

Fangfang Xiang, MD

CONTACT

+86 13816209067; xiang.fangfang@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share