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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• Treated at an in-centre dialysis clinic

• Receiving chronic, maintenance HD

Locations
Other Locations
France
AURA
RECRUITING
Paris
Contact Information
Primary
Roberto Pecoits-filho, MD
Roberto.Pecoits@arborresearch.org
7342108046
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 1000
Treatments
External control: DOPPS cohort
DOPPS study in Europe
Related Therapeutic Areas
Sponsors
Leads: Arbor Research Collaborative for Health

This content was sourced from clinicaltrials.gov