Comparisons Of Biochemical And Clinical Outcomes Of Hemodialysis Patients Treated With Middle Cut-Off Dialyzers Versus High-Flux Hemodialysis Or Hemodiafiltration

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorArbor Research Collaborative for Health

About this trial

The CONCORDIA study is a retrospective, observational study evaluating clinical and biochemical outcomes among patients receiving maintenance hemodialysis with medium cut-off (MCO) dialyzers (Theranova) compared with high-flux hemodialysis (HF-HD) and hemodiafiltration (HDF). Using real-world data from non-DOPPS Theranova sites and the DOPPS cohort as an external control, the study aims to assess whether MCO dialyzers are associated with improved outcomes versus HF-HD and non-inferior outcomes compared with HDF. The primary outcome is all-cause mortality, with secondary outcomes including cardiovascular events, hospitalizations, infections, and laboratory measures related to anemia, mineral metabolism, and inflammation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Treated at an in-centre dialysis clinic

Receiving chronic, maintenance HD

Disqualifiers

None

Trial population

Inclusion Criteria * 18 years of age or older * Treated at an in-centre dialysis clinic * Receiving chronic, maintenance HD

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: External control: DOPPS cohort

Trial outcomes

Primary outcomes

1

All Cause Mortality

Death from any cause

Time frame
3 years
2

All cause mortality

Time frame
From 2017 to 2023

Secondary outcomes

Other outcomes

Sponsors and contacts

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