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Age ProblemNCT06141798

Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients

A study testing Hemodialysis in people with Age Problem and Dialysis; Complications, run by Soonchunhyang University Hospital at 7 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Age Problem, Dialysis; Complications, Frailty
What is being tested?
Hemodialysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
428 participants
Where
7 sitesSouth Korea
Study dates
23 Nov 2021to 31 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Soon Hyo Kwon, MD contact

+8227099177

ksoonhyo@schmc.ac.kr

7 sites in 1 country

South Korea7 sites, 1 recruiting
  • Soonchunhyang University Hospital Bucheon

    Bucheon-si

    Byung Chul Yu, MD

    Recruiting
  • Hallym University Medical Center- Chuncheon

    Chuncheon

    Completed
  • Soonchunhyang University Seoul Hospital

    Seoul, 04401

    Active, not recruiting
  • Kangbuk Samsung Medical Center

    Seoul

    Completed
  • Koera University Guro Hospital

    Seoul

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

    Seoul

    Completed
  • Yonsei University, Wonju Severance Christian Hospital

    Wŏnju

    Completed

Other trials in South Korea

About this study

Official title: A Pragmatic Randomized Clinical Trial: Twice-weekly vs Thrice-weekly Incident hemoDialysis in Elderly Patients

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.

Read the detailed description

End-stage kidney disease (ESKD) poses a substantial public health challenge, with the number of patients requiring renal replacement therapy (RRT) globally reaching 2.61 million in 2010 and projected to rise to 5.43 million by 2030. In Korea, the incidence of hemodialysis (HD) has also been gradually increasing. The increase in HD incidence in South Korea is significantly linked to the aging population. Korea is one of the most rapidly aging countries in the world and the age of dialysis patients is also increasing, with more than half over the age of 60.

HD has potential advantages over conservative management or peritoneal dialysis in older adults, however, guidelines for optimal HD for the elderly have not yet been established. Typically, patients receive HD three times a week, with only a small proportion of patients receiving less frequent dialysis. However, potential disadvantages such as hemodynamic stress, vascular access problems, bleeding, falls and economic cost should be considered in older adults with ESKD.

In elderly patients, it is often difficult to maintain a thrice-weekly HD schedule due to the presence of other medical conditions and the challenges of frailty. Elderly patients have shown poor outcome even after initiation of HD. A study by Santos et al. demonstrated a more than twofold increased risk of mortality at 6 months in patients older than 75 years compared to those younger than 75. Another study using Japanese National Dialysis Registry data revealed a 30% mortality rate in those aged over 80 years within 1 year after initiation of HD, with frailty being one of the most important factors associated with early death after initiation of HD. Excessive HD in elderly patients can lead to malnutrition, low blood pressure during dialysis, poor quality of life, depression, and stress due to physical and temporal activity restriction. The increased risk of falls in HD patients is also a serious problem.

Incremental initiation of HD involves starting HD at a lower intensity than the standard 4 hours thrice weekly and gradually increasing the frequency and duration of dialysis as kidney function declines. The decision to initiate patients on incremental HD can be made based on clinical parameters such as urine volume or residual kidney function, socio-economic factors such as financial limitations or insurance coverage, or lack of availability of dialysis services. Current guidelines recommend that twice weekly dialysis be performed in patients with kidney urea clearance greater than 3ml/min/1.73m2 or a urine output over 0.5 liter per day.

A systemic review and meta-analysis showed no difference in mortality, hospitalization rates, or quality of life between patients receiving incremental and conventional HD, with improved preservation of residual renal function and a reduction in dialysis cost with incremental HD. One randomized controlled trial (RCT) showed no difference in episodes of fluid overload or hyperkalemia, but an increased risk of hyperkalemia with incremental HD. Another study showed lower hospitalization rate in incremental HD compared to conventional dialysis. These studies demonstrate the need for a large RCT comparing incremental and conventional HD.

However, current studies do not provide conclusive evidence on the benefits and risks of incremental HD in elderly patients. Therefore, the investigators are conducting a pragmatic RCT to determine whether the initiation of renal replacement therapy with twice-weekly HD reduces hospitalization rates compared to conventional thrice-weekly HD in older adults with ESKD.

Trial design PRIDE trial is designed as a pragmatic RCT comparing the effect of initiating twice-weekly hemodialysis with an incremental approach compared to thrice-weekly HD on hospitalization rates in elderly ESKD patients with RKF. A total of 428 participants will be recruited from 18 academic dialysis centers in Korea. Participants will have the flexibility to transfer to other dialysis centers as needed. The decision to increase dialysis frequency will be made by the treating physicians.

Hypothesis Our main hypothesis is that twice-weekly HD, when prescribed to older adults with RKF will reduce hospitalization rates compared with thrice-weekly HD.

  1. Liyanage T, Ninomiya T, Jha V, et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet 2015;385:1975-1982.
  2. Hong YA, Ban TH, Kang CY, et al. Trends in epidemiologic characteristics of end-stage renal disease from 2019 Korean Renal Data System (KORDS). Kidney Res Clin Pract 2021;40:52-61.
  3. Choi HS, Han KD, Oh TR, et al. Trends in the incidence and prevalence of end-stage renal disease with hemodialysis in entire Korean population: A nationwide population-based study. Medicine (Baltimore) 2021;100:e25293.
  4. Verberne WR, Geers AB, Jellema WT, Vincent HH, van Delden JJ, Bos WJ. Comparative Survival among Older Adults with Advanced Kidney Disease Managed Conservatively Versus with Dialysis. Clin J Am Soc Nephrol 2016;11:633-640.
  5. Corbett RW, Brown EA. Conventional dialysis in the elderly: How lenient should our guidelines be? Semin Dial 2018;31:607-611.
  6. Bieber B, Qian J, Anand S, et al. Two-times weekly hemodialysis in China: frequency, associated patient and treatment characteristics and Quality of Life in the China Dialysis Outcomes and Practice Patterns study. Nephrol Dial Transplant 2014;29:1770-1777.
  7. Santos J, Oliveira P, Malheiro J, et al. Predicting 6-Month Mortality in Incident Elderly Dialysis Patients: A Simple Prognostic Score. Kidney Blood Press Res 2020;45:38-50.
  8. Yazawa M, Kido R, Ohira S, et al. Early Mortality Was Highly and Strongly Associated with Functional Status in Incident Japanese Hemodialysis Patients: A Cohort Study of the Large National Dialysis Registry. PLoS One 2016;11:e0156951.
  9. Buemi M, Lacquaniti A, Bolignano D, et al. Dialysis and the elderly: an underestimated problem. Kidney Blood Press Res 2008;31:330-336.
  10. Wang HH, Wu JL, Lee YC, et al. Risk of Serious Falls Between Hemodialysis and Peritoneal Dialysis Patients: A Nationwide Population-based Cohort Study. Sci Rep 2020;10:7799.
  11. Caton E, Sharma S, Vilar E, Farrington K. Impact of incremental initiation of haemodialysis on mortality: a systematic review and meta-analysis. Nephrol Dial Transplant 2023;38:435-446.
  12. Hemodialysis Adequacy Work G. Clinical practice guidelines for hemodialysis adequacy, update 2006. Am J Kidney Dis 2006;48 Suppl 1:S2-90.
  13. Kalantar-Zadeh K, Unruh M, Zager PG, et al. Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy. Am J Kidney Dis 2014;64:181-186.
  14. Vilar E, Kaja Kamal RM, Fotheringham J, et al. A multicenter feasibility randomized controlled trial to assess the impact of incremental versus conventional initiation of hemodialysis on residual kidney function. Kidney Int 2022;101:615-625.
  15. Murea M, Patel A, Highland BR, et al. Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study. Am J Kidney Dis 2022;80:227-240 e221.
Being tested
Hemodialysis
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HemodialysisOther

    Number of weekly hemodialysis treatment

Study groups in NCT06141798
Study groupRoleWhat they receive
Twice-weekly hemodialysis with incremental approachActive comparatorNot described
Receives: Other: Hemodialysis
Thrice-weekly hemodialysisNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalization rate

    The total number of hospitalizations per 100 person-years

    Measured: Follow up: 2 years

Secondary outcomes (7)
  1. Dialysis related hospitalization rate

    The total number of dialysis hospitalizations per 100 person-years

    Measured: Follow up: 2 years

  2. Length of Hospital Stay

    per 1000 person-days

    Measured: Follow up: 2 years

  3. Complication of dialysis

    Any complication of dialysis associated

    Measured: Follow up: 2 years

  4. Mortality rate

    Any cause of death

    Measured: Follow up: 2 years

  5. The Clinical Frailty Scale

    One item, minimum point: 1, maximum point: 9, High scores means worse outcome

    Measured: Follow up: 2 years

  6. Cost effective

    Incremental Cost-Effectiveness Ratio, Higher scores means better

    Measured: Follow up: 2 years

  7. Kidney Disease Quality of Life Instrument (KDQOL)

    24 items, minimum point 1, maximum point 5, high score means worse outcomes

    Measured: Follow up: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2023
  2. Study start23 Nov 2021
  3. Primary completion9 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic Randomization Trial
Masking
None (open label)
Enrolment
428 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06141798
Sponsor's protocol ID
HC21C0059
Status last verified
May 2025
First submitted
7 Oct 2023
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38148125

Questions about this trial

What is this clinical trial studying?

A study testing Hemodialysis in people with Age Problem and Dialysis; Complications, run by Soonchunhyang University Hospital at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Soon Hyo Kwon, MD (+8227099177, ksoonhyo@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization rate (time frame: Follow up: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06141798, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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