NCT06141798 Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients
| NCT ID | NCT06141798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Soonchunhyang University Hospital |
| Condition | Age Problem |
| Study Type | INTERVENTIONAL |
| Enrollment | 428 participants |
| Start Date | 2021-11-23 |
| Primary Completion | 2026-05-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 428 participants in total. It began in 2021-11-23 with a primary completion date of 2026-05-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
As Korea is becoming a super-aged society, the number of elderly patients with end-stage kidney disease (ESKD) is expected to increase rapidly. Therefore, the burden on Korean society will also increase. Thrice-weekly hemodialysis is standard for renal replacement therapy. However, this regimen has not been validated for elderly ESKD patients with residual renal function. Elderly patients can have multiple comorbidities such as hypertension, diabetes, cardiovascular disease, and impaired physical activity. Frequent hemodialysis could provoke falls, hypotension, and cognitive impairment. Previous reports have suggested the potential benefit of twice-weekly hemodialysis with incremental increases in frequency when residual renal function decreases. In addition, twice-weekly hemodialysis decreases hospitalization rates in frail patients. Therefore, the investigators hypothesized initiating renal replacement therapy with twice-weekly hemodialysis decreases the hopsitalizatoin rates compared with conventional thrice-weekly hemodialysis in elderly ESRD patients with residual renal function. This study is a pragmatic randomized clinical trial, multicenter study. Study subjects are incident ESRD patients (\>= 60 years old, n=428) with residual urine volume ( \> 500 mL/day) and follow up up to 2 years. Twice-weekly hemodialysis could be incremented according to clinical situations such as volume overload, hyperkalemia and uremic symptom. Primary outcome of this study is hospitalization rate during follow-up. Secondary outcomes include dialysis related hospitalization rate, the length of hospital stay, complication of dialysis,mortality rate and assessments of quality of life, frailty, and cost-utility.
Eligibility 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.
Contact & Investigator
Soon Hyo Kwon, MD
PRINCIPAL INVESTIGATOR
Soonchunhyang University Hospital
Frequently Asked Questions
Who can join the NCT06141798 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Age Problem. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06141798 currently recruiting?
Yes, NCT06141798 is actively recruiting participants. Contact the research team at ksoonhyo@schmc.ac.kr for enrollment information.
Where is the NCT06141798 trial being conducted?
This trial is being conducted at Bucheon-si, South Korea, Chuncheon, South Korea, Seoul, South Korea, Seoul, South Korea and 3 additional locations.
Who is sponsoring the NCT06141798 clinical trial?
NCT06141798 is sponsored by Soonchunhyang University Hospital. The principal investigator is Soon Hyo Kwon, MD at Soonchunhyang University Hospital. The trial plans to enroll 428 participants.