Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients
A Pragmatic Randomized Clinical Trial: Twice-weekly vs Thrice-weekly Incident hemoDialysis in Elderly Patients
1 other identifier
interventional
428
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2021
CompletedFirst Submitted
Initial submission to the registry
October 7, 2023
CompletedFirst Posted
Study publicly available on registry
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
May 31, 2024
May 1, 2024
4.5 years
October 7, 2023
May 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Hospitalization rate
The total number of hospitalizations per 100 person-years
Follow up: 2 years
Secondary Outcomes (7)
Dialysis related hospitalization rate
Follow up: 2 years
Length of Hospital Stay
Follow up: 2 years
Complication of dialysis
Follow up: 2 years
Mortality rate
Follow up: 2 years
The Clinical Frailty Scale
Follow up: 2 years
- +2 more secondary outcomes
Study Arms (2)
Twice-weekly hemodialysis with incremental approach
ACTIVE COMPARATORThrice-weekly hemodialysis
NO INTERVENTIONInterventions
Number of weekly hemodialysis treatment
Eligibility Criteria
You may qualify if:
- Age ≥60 years
- Clinical diagnosis of end stage kidney disease
- Starting maintenance hemodialysis within one month
- hour urine output ≥ 500 ml at randomization
- Sufficient understanding of the study procedures and requirements.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Soonchunhyang University Hospital Bucheon
Bucheon-si, South Korea
Hallym University Medical Center- Chuncheon
Chuncheon, South Korea
Soonchunhyang University Seoul Hospital
Seoul, 04401, South Korea
Kangbuk Samsung Medical Center
Seoul, South Korea
Koera University Guro Hospital
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, South Korea
Related Publications (1)
Han M, Jeon H, Yu BC, Song SH, Chung S, Lim C, Sohn H, Noh JW, Kwon SH. A Pragmatic Randomized clinical trial: twice-weekly vs. thrice-weekly Incident hemoDialysis in Elderly patients (PRIDE): study protocol. Kidney Res Clin Pract. 2026 Jan;45(1):130-139. doi: 10.23876/j.krcp.23.177. Epub 2023 Dec 18.
PMID: 38148125BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soon Hyo Kwon, MD
Soonchunhyang University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 7, 2023
First Posted
November 21, 2023
Study Start
November 23, 2021
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
May 31, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share