NCT07278973

Brief Summary

This study will compare the impact of two hemodialysis techniques on fatigue and post-dialysis recovery time in patients aged 85 years and older. These two techniques are high-flux hemodialysis (HD) and hemodiafiltration (HDF). Patients will receive the treatment over two periods: if period 1 is HD then period 2 will be HDF. Every patient will be his/her own control, this is why it is called cross-over. Each period will last three months. Between the two periods, patients will receive a traditional low-flux hemodialysis. These two techniques are widely used worldwide and their side-effects are well-known and do not put the patients at risk. HDF has been shown to improve survival in patients with a mean age of 58 years. But a previous study from the investigators' group showed that HDF causes a prolonged recovery time in older patients. This randomized trial aims to elucidate this question.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

September 18, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 19, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

September 18, 2025

Last Update Submit

February 20, 2026

Conditions

HemodialysisHemodiafiltrationFatigue SymptomQuality of Life of PatientsOlder People

Keywords

HemodialysisHemodiafiltrationOlder peopleFatiguePatient reported outcomeDialysis recovery time

Outcome Measures

Primary Outcomes (1)

  • Change in dialysis recovery time

    Time in minutes that the patient needs after dialysis to recover energy

    Three months

Secondary Outcomes (12)

  • Change in fatigue score

    Three months

  • Change in STS-30

    Three months

  • Change in SF-12 scores

    Three months

  • Number of episodes of of symptomatic hypotension

    Three months

  • Number of intradialytic clotting events

    Three months

  • +7 more secondary outcomes

Study Arms (2)

Sequence 1: HD HDF

EXPERIMENTAL

The patient will receive three months of HD followed by three months of HDF

Other: High-flux hemodialysisOther: Hemodiafiltration

Sequence 2: HDF HD

EXPERIMENTAL

The patient will receive three months of HDF followed by three months of HD

Other: High-flux hemodialysisOther: Hemodiafiltration

Interventions

High-flux hemodialysisOTHER

High-flux hemodialysis removes small and middle molecular solutes through the mechanism of diffusion.

Sequence 1: HD HDFSequence 2: HDF HD
HemodiafiltrationOTHER

Hemodiafiltration removes solutes using convection which allows for more epuration of middle molecular solutes.

Sequence 1: HD HDFSequence 2: HDF HD

Eligibility Criteria

Age85 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Signed and dated informed consent
  • Age \>84 years
  • Diagnosed with kidney failure
  • On maintenance hemodialysis \>3months
  • Willing to have a dialysis session of 3.5 to 4-hour duration, three times a week
  • Has a reliable vascular access
  • Is covered by the health insurance

You may not qualify if:

  • Patients with cognitive impairment (assessed with a mini-test if needed)
  • Have difficulties with French speaking
  • Terminally ill with life expectancy\<3 months
  • With active cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

AUB Santé

Bretagne, France

RECRUITING

AIDER

Grabels, 34790, France

RECRUITING

ECHO

Le Mans, France

RECRUITING

Aura Paris

Paris, France

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Hemodiafiltration

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal DialysisRenal Replacement TherapyTherapeuticsSorption DetoxificationHemofiltrationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Mabel Aoun, M.D., M.P.H.

    AUB SANTE

    STUDY CHAIR

Central Study Contacts

Mabel AOUN, M.D., M.P.H.

CONTACT

+33174743551aounmabel@yahoo.fr

Sibylle Gourvil

CONTACT

02.90.22.64.05sibylle.gourvil@aub-sante.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Data analysis
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrologist

Study Record Dates

First Submitted

September 18, 2025

First Posted

December 12, 2025

Study Start

February 19, 2026

Primary Completion (Estimated)

December 19, 2026

Study Completion (Estimated)

December 19, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations

FR(4)