Hemodialysis with Theranova MCO dialyzers versus high‑flux dialysis and hemodiafiltration
Official title: Comparisons Of Biochemical And Clinical Outcomes Of Hemodialysis Patients Treated With Middle Cut-Off Dialyzers Versus High-Flux Hemodialysis Or Hemodiafiltration
Run by Arbor Research Collaborative for Health · NCT07561424 · Data updated 2026-11-12
This project tests whether using Theranova medium cut‑off dialyzers for adults on in‑center maintenance hemodialysis lowers the risk of death and other complications compared with high‑flux hemodialysis or hemodiafiltration.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Arbor Research Collaborative for Health Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | June 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07561424 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who receive chronic, in‑center maintenance hemodialysis at participating clinics are the intended candidates.
✕Probably not a fit
Patients on peritoneal dialysis, home hemodialysis, or receiving only acute/short‑term dialysis are unlikely to be included or benefit from the comparisons made here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
CONCORDIA is a retrospective, observational real‑world evidence comparison of adults on maintenance hemodialysis treated with medium cut‑off (MCO/Theranova) dialyzers versus high‑flux hemodialysis (HF‑HD) and hemodiafiltration (HDF). The study uses routine clinical and laboratory data from non‑DOPPS Theranova sites together with the DOPPS cohort as an external control to compare outcomes. The primary outcome is all‑cause mortality, and secondary outcomes include cardiovascular events, hospitalizations, infections, and laboratory measures related to anemia, mineral metabolism, and inflammation. Analyses will adjust for patient characteristics to account for baseline differences and explore whether MCO use is associated with improved biochemical and clinical outcomes or non‑inferior results compared with HDF.
Why it matters
Potential benefit: If positive, using MCO/Theranova dialyzers could reduce mortality and complications by better clearing middle molecules without the infrastructure needs of hemodiafiltration.
How similar studies have gone: Prior physiological and smaller observational studies have shown improved middle‑molecule clearance and some biomarker improvements with MCO membranes, but consistent reductions in mortality have not been clearly demonstrated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * 18 years of age or older * Treated at an in-centre dialysis clinic * Receiving chronic, maintenance HD
Where it's running
-
Aura
Paris, France Recruiting
Study contacts
- Study coordinator: Roberto Pecoits-filho, MD
- Email: Roberto.Pecoits@arborresearch.org
- Phone: 7342108046
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.