Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT06141798

Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients

Led by Soonchunhyang University Hospital · Updated on 2026-05-11

428

Participants Needed

7

Research Sites

235 weeks

Total Duration

On this page

Sponsors

S

Soonchunhyang University Hospital

Lead Sponsor

M

Ministry of Health & Welfare, Korea

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Clinical diagnosis of end stage kidney disease
  • Starting maintenance hemodialysis within one month
  • 24-hour urine output at least 500 milliliters at randomization
  • Sufficient understanding of the study procedures and requirements
Not Eligible

You will not qualify if you...

  • Left ventricular ejection fraction less than 40%
  • Liver cirrhosis
  • Current treatment for an active malignancy or active infection
  • Inability or refusal to provide written informed consent
  • Enrollment in another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Soonchunhyang University Hospital Bucheon

Bucheon-si, South Korea

Actively Recruiting

2

Hallym University Medical Center- Chuncheon

Chuncheon, South Korea

Completed

3

Soonchunhyang University Seoul Hospital

Seoul, South Korea, 04401

Active, Not Recruiting

4

Kangbuk Samsung Medical Center

Seoul, South Korea

Completed

5

Koera University Guro Hospital

Seoul, South Korea

Completed

6

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, South Korea

Completed

7

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, South Korea

Completed

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Research Team

S

Soon Hyo Kwon, MD

CONTACT

S

Sook Kim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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