Comparing Twice vs Thrice Weekly Hemodialysis for Elderly Patients
A Pragmatic Randomized Clinical Trial: Twice-weekly vs Thrice-weekly Incident hemoDialysis in Elderly Patients
This study tests whether doing hemodialysis twice a week instead of three times can help elderly patients with kidney disease feel better and stay out of the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 428 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Soonchunhyang University Hospital Academic / other |
| Locations | 7 sites (Bucheon-si and 6 other locations) |
| Trial ID | NCT06141798 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of initiating hemodialysis treatment twice weekly versus the standard thrice weekly regimen in elderly patients with end-stage kidney disease (ESKD). The study aims to assess whether a less frequent dialysis schedule can reduce hospitalization rates and improve quality of life for frail elderly patients who may have multiple comorbidities. By focusing on patients with residual renal function, the trial seeks to validate a potentially safer and more effective approach to renal replacement therapy in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 years and older who are starting maintenance hemodialysis and have some residual renal function.
Not a fit: Patients with severe cardiac issues, liver cirrhosis, active malignancies, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes and quality of life for elderly patients undergoing hemodialysis.
How similar studies have performed: While the approach of less frequent hemodialysis is being explored, this specific comparison in elderly patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥60 years * Clinical diagnosis of end stage kidney disease * Starting maintenance hemodialysis within one month * 24-hour urine output ≥ 500 ml at randomization * Sufficient understanding of the study procedures and requirements. Exclusion Criteria: * Left ventricular ejection fraction \< 40%) * Liver cirrhosis * Current treatment for an active malignancy or active infection * Onability or refusal to provide written informed consent * enrollment in another clinical trial.
Where this trial is running
Bucheon-si and 6 other locations
- Soonchunhyang University Hospital Bucheon — Bucheon-si, South Korea (Recruiting)
- Hallym University Medical Center- Chuncheon — Chuncheon, South Korea (Completed)
- Soonchunhyang University Seoul Hospital — Seoul, South Korea (Active_not_recruiting)
- Kangbuk Samsung Medical Center — Seoul, South Korea (Completed)
- Koera University Guro Hospital — Seoul, South Korea (Completed)
- The Catholic University of Korea, Yeouido St. Mary's Hospital — Seoul, South Korea (Completed)
- Yonsei University, Wonju Severance Christian Hospital — Wŏnju, South Korea (Completed)
Study contacts
- Principal investigator: Soon Hyo Kwon, MD — Soonchunhyang University Hospital
- Study coordinator: Soon Hyo Kwon, MD
- Email: ksoonhyo@schmc.ac.kr
- Phone: +8227099177
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.