Dialysis method comparison for people aged 85 and older
HemoDiafiltration Versus HemoDialysis in OLDER People: a Randomized, Multicenter, Crossover, Pragmatic Clinical Trial
NA · AUB Santé · NCT07278973
This test will compare hemodiafiltration and high-flux hemodialysis to see which gives shorter recovery time and less fatigue for people aged 85 and older.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 85 Years and up |
| Sex | All |
| Sponsor | AUB Santé (other) |
| Locations | 4 sites (Bretagne and 3 other locations) |
| Trial ID | NCT07278973 on ClinicalTrials.gov |
What this trial studies
This randomized, multicenter crossover trial enrolls patients aged 85 and older who are on maintenance hemodialysis and assigns them to two 3-month periods of either hemodiafiltration (HDF) or high-flux hemodialysis (HD) with a two-week low-flux washout between periods. Each participant serves as their own control, with sequence randomized 1:1 and treatments unblinded. Primary outcome is dialysis recovery time, and secondary outcomes include general fatigue and patient-reported symptoms collected during the treatment periods. The aim is to determine which commonly used dialysis modality leads to faster recovery and better quality of life in very old patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 85 or older who have end-stage kidney failure, have been on maintenance hemodialysis for more than three months, can attend thrice-weekly 3.5–4 hour sessions, have reliable vascular access, and can provide informed consent in French.
Not a fit: Patients who are terminally ill, have active cancer, significant cognitive impairment, are hospitalized at enrollment, cannot speak French, or who are younger than 85 are unlikely to benefit from or be eligible for this trial.
Why it matters
Potential benefit: If successful, the results could show which dialysis method helps very old patients recover faster and feel less fatigued after treatment.
How similar studies have performed: Previous studies found HDF improved survival in younger populations (mean age ~58), but earlier work by these investigators suggested HDF may prolong recovery time in older patients, so evidence in very old adults is mixed and inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with cognitive impairment (assessed with a mini-test if needed) * Hospitalized at inclusion * Have difficulties with French speaking * Terminally ill with life expectancy\<3 months * With active cancer
Where this trial is running
Bretagne and 3 other locations
- AUB Santé — Bretagne, France (RECRUITING)
- AIDER — Grabels, France (RECRUITING)
- ECHO — Le Mans, France (RECRUITING)
- Aura Paris — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Mabel AOUN, M.D., M.P.H.
- Email: aounmabel@yahoo.fr
- Phone: +33174743551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemodialysis, Hemodiafiltration, Fatigue Symptom, Quality of Life of Patients, Older People, Older people, Fatigue, Patient reported outcome