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

April 28, 2026 updated by: Roberto Pecoits-Filho, Arbor Research Collaborative for Health
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The CONCORDIA study is an observational, real-world evidence investigation designed to evaluate the comparative effectiveness of dialysis modalities, specifically focusing on medium cut-off (MCO) dialyzers (Theranova) versus high-flux hemodialysis (HF-HD) and hemodiafiltration (HDF). The study is motivated by the persistently high mortality rates among hemodialysis patients and the substantial variation in outcomes across regions, suggesting that treatment practices may play a key role in influencing patient outcomes.

Conventional hemodialysis effectively removes small uremic toxins but is limited in clearing larger middle molecules, which are believed to contribute to morbidity and mortality. HDF improves clearance of these molecules but requires more complex infrastructure and higher costs. MCO membranes, such as Theranova, have been developed to enhance removal of middle and large middle molecules without requiring significant changes to dialysis delivery, representing a potentially scalable alternative.

The primary objective of the CONCORDIA study is to determine whether the use of Theranova dialyzers is associated with lower all-cause mortality compared to HF-HD. Secondary objectives include assessing whether Theranova improves biochemical outcomes relative to HF-HD and whether it is non-inferior to HDF in terms of both clinical and biochemical outcomes. Additional analyses will explore patient characteristics associated with Theranova use.

The study adopts a retrospective observational design, leveraging the extensive infrastructure of the Dialysis Outcomes and Practice Patterns Study (DOPPS) as a control cohort. Patients treated with Theranova will be recruited from non-DOPPS facilities with high utilization of MCO dialyzers, primarily in Europe. The expected sample includes approximately 500-1000 Theranova patients, compared with DOPPS cohorts of HF-HD and HDF patients.

Eligible participants are adults (≥18 years) receiving in-center maintenance hemodialysis. Data will be collected retrospectively from March to June 2026 and include demographics, comorbidities, laboratory values, dialysis prescriptions, medication use, and clinical outcomes such as mortality, cardiovascular events, infections, and hospitalizations. Data are pseudonymized to ensure patient confidentiality, including date shifting and variable binning techniques.

The primary outcome is all-cause mortality. Secondary outcomes include major adverse cardiovascular events (MACE), infection-related events, hospitalizations, and a range of biochemical parameters (e.g., hemoglobin, ferritin, phosphorus, CRP, beta-2 microglobulin). Additional outcomes include measures of volume status, blood pressure, and medication utilization.

Analytically, the study will use Cox proportional hazards models with sequential adjustment for confounders, including demographics, comorbidities, and treatment factors. Matching and multivariable adjustment will be employed to mitigate confounding by indication. Both superiority (Theranova vs HF-HD) and non-inferiority (Theranova vs HDF) analyses will be conducted. The non-inferiority margin is informed by prior randomized trial data comparing HDF and HF-HD.

Overall, CONCORDIA aims to generate robust real-world evidence on the comparative effectiveness of MCO dialyzers, informing clinical practice and supporting future trial design.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Inclusion Criteria

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

Description

Inclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
External control: DOPPS cohort
DOPPS study in Europe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cause Mortality
Time Frame: 3 years
Death from any cause
3 years
All cause mortality
Time Frame: From 2017 to 2023
From 2017 to 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbor Research Collaborative for Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dialysis Patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe