NCT07561424

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Feb 2026Sep 2026

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

March 23, 2026

Last Update Submit

April 28, 2026

Conditions

ESKDDialysis Patients

Keywords

dialysisHDF

Outcome Measures

Primary Outcomes (2)

  • All Cause Mortality

    Death from any cause

    3 years

  • All cause mortality

    From 2017 to 2023

Study Arms (1)

External control: DOPPS cohort

DOPPS study in Europe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AURA

Paris, France

RECRUITING

Central Study Contacts

Roberto Pecoits-filho, MD

CONTACT

7342108046Roberto.Pecoits@arborresearch.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

March 23, 2026

First Posted

May 1, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)