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RECRUITING
NCT07561424

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

Sponsor: Arbor Research Collaborative for Health

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-02-01

Completion Date

2026-09-01

Last Updated

2026-05-01

Healthy Volunteers

No

Locations (1)

AURA

Paris, France