Incremental Hemodialysis for Chronic Kidney Disease

(INCHVETS Trial)

Recruiting at 5 trial locations

Overseen By Kamyar Kalantar-Zadeh, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Terminal illness, High potassium, others

Compensation: Varies

Number of Visits: 6

Duration: 12 months

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether starting dialysis less frequently can be safe and beneficial for Veterans with chronic kidney disease who are beginning dialysis. Researchers compare the usual three-times-a-week dialysis (Thrice-Weekly Hemodialysis) with starting at twice-a-week and gradually increasing to three-times-a-week over a year (Incremental Hemodialysis). They aim to determine if less frequent dialysis helps maintain kidney function longer and improves quality of life. Veterans who produce enough urine and are willing to try either dialysis schedule may be suitable for this trial.

As an unphased trial, this study offers Veterans the chance to contribute to innovative research that could enhance dialysis treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that starting hemodialysis with fewer sessions and gradually increasing them is generally safe. Studies have found that this method can lead to good results, especially with carefully selected patients. For instance, a review suggested that this approach might even be better for some patients.

However, safety can vary based on individual health conditions. One study noted a higher risk of issues for patients with very low kidney function at the beginning. While many people handle incremental hemodialysis well, doctors must closely monitor to ensure it remains safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a flexible approach to hemodialysis for patients with chronic kidney disease. Typically, patients undergo thrice-weekly hemodialysis as the standard of care. However, this trial is investigating a method that starts with twice-weekly sessions and gradually increases to thrice-weekly, only if needed. This incremental approach might offer more personalized treatment, potentially improving patient comfort, reducing treatment burden, and maintaining kidney function for longer. By tailoring the dialysis frequency to individual needs, researchers hope to optimize treatment outcomes and enhance quality of life for patients.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Research has shown that starting dialysis twice a week and gradually increasing it can benefit some people with chronic kidney disease. In this trial, participants will follow either a twice-weekly hemodialysis schedule with an incremental crossover to thrice-weekly sessions as needed, or a thrice-weekly schedule without the option to reduce frequency. Studies have found that the twice-weekly method can be safe and might improve quality of life compared to starting with more frequent sessions. Specifically, a study of 312 patients in China found that those who began with less frequent dialysis reported a better quality of life. This approach also helps preserve remaining kidney function longer. However, it might not suit everyone, especially those with very low kidney function at the start of dialysis. ^{2 3 4 5 6}

Who Is on the Research Team?

Kamyar Kalantar-Zadeh, MD PhD

Principal Investigator

VA Long Beach Healthcare System, Long Beach, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with end-stage renal disease (ESRD) who are starting dialysis. Participants must produce a certain amount of urine daily, agree to study procedures and interviews, and have started hemodialysis within the last 8 weeks at one of six VA centers. Those with very high potassium levels or terminal illnesses with less than 6 months to live are excluded.

Inclusion Criteria

I am willing to attend all required study tests, in person or via telehealth.

I am willing to follow a treatment plan that could be 2 or 3 times a week.

I agree to monthly reviews and interviews for the study.

Exclusion Criteria

Your blood potassium level was too high in the month before the study.

I have a terminal illness and am expected to live less than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either twice-weekly or thrice-weekly hemodialysis, with incremental crossover to thrice-weekly as indicated

12 months

Routine outpatient dialysis clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of HRQOL, RKF, and other health measures

4 weeks

Sub-study

In a subset of 112 participants, additional cardiac and physical performance measures are assessed

12 months

Assessments at baseline, Month 6, and Month 12

What Are the Treatments Tested in This Trial?

Interventions

• Thrice-Weekly Hemodialysis
• Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule

Trial Overview The study compares two dialysis schedules: usual thrice-weekly versus twice-weekly that increases to three times over a year. It aims to see if starting with fewer sessions helps patients cope better, maintains kidney function longer, and offers cost benefits without compromising safety.

How Is the Trial Designed?

Group I: Twice-Weekly Hemodialysis Experimental Treatment 1 Intervention

Twice-weekly hemodialysis with incremental crossover to thrice-weekly hemodialysis as indicated

Group II: Thrice-Weekly Hemodialysis Placebo Group 1 Intervention

Outright thrice-weekly hemodialysis without option to switch to less frequent dialysis schedule

Thrice-Weekly Hemodialysis is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hemodialysis for:

• End-stage renal disease (ESRD)
• Chronic kidney disease

Approved in European Union as Hemodialysis for:

• End-stage renal disease (ESRD)
• Chronic kidney disease

Approved in Canada as Hemodialysis for:

• End-stage renal disease (ESRD)
• Chronic kidney disease

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A systematic review of 21 cohort studies found no randomized controlled trials comparing twice weekly to thrice weekly hemodialysis, indicating a lack of high-quality evidence in this area.

While the overall outcomes were variable, the twice weekly hemodialysis group showed a consistently slower decline in residual kidney function compared to the thrice weekly group, suggesting a potential benefit in preserving kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice versus thrice weekly hemodialysis: A systematic review. Moorman, D., Pilkey, NG., Goss, CJ., et al.[2022]

A study involving 26 participants revealed that patients with kidney failure strongly prefer an incremental approach to hemodialysis (HD), which involves starting with less than three sessions per week, to minimize disruption to their daily lives.

The most important outcomes for patients were quality of life, residual kidney function, and mortality, indicating that patients prioritize their overall well-being and daily functioning over strict adherence to traditional HD schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Australian Workshops on Patients' Perspectives on Hemodialysis and Incremental Start. Hegerty, K., Jaure, A., Scholes-Robertson, N., et al.[2023]

Incremental hemodialysis (iHD), which involves once or twice weekly dialysis, may be a beneficial alternative to the standard thrice weekly schedule for patients with end-stage chronic kidney disease, as it can ease the transition into dialysis and potentially preserve residual kidney function longer.

Despite the advantages of iHD, such as improved patient quality of life and reduced 'dialysis shock', there are currently no standardized guidelines for its implementation, leading to variability in practice across different healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ABCs of personalized incremental dialysis start, Le Mans style. Torreggiani, M., Fois, A., Samoreau, C., et al.[2023]

Twice-weekly hemodialysis may be a safe and effective treatment option for patients with substantial residual kidney function (RKF), potentially preserving RKF and vascular access longer than the standard thrice-weekly regimen.

Proposed criteria for selecting patients for twice-weekly hemodialysis include having a urine output greater than 500 ml/day and favorable health conditions, suggesting that individualized treatment plans could enhance patient quality of life and warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is Known and Unknown About Twice-Weekly Hemodialysis. Obi, Y., Eriguchi, R., Ou, SM., et al.[2018]

A pilot study involving 51 patients assessed the feasibility and safety of incremental-start hemodialysis (HD), showing high adherence rates (96%) to the treatment schedule and successful enrollment in a randomized study.

Patients in the incremental HD group experienced less decline in urine volume and solute clearance compared to those receiving conventional thrice-weekly HD, suggesting potential benefits of this approach, although further research with larger trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study. Murea, M., Patel, A., Highland, BR., et al.[2023]

Recent randomized clinical trials indicate that more frequent hemodialysis (HD) therapies, such as short daily and long nocturnal HD, can improve control of hypertension and hyperphosphatemia, but may lead to increased vascular access complications and faster loss of residual kidney function.

In the West, the standard HD prescription is three sessions per week, while in less developed Asian countries, many patients only receive twice weekly sessions due to financial constraints, highlighting disparities in access to care and treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Hemodialysis Therapy in the West. Rocco, MV.[2020]

A study of 241,093 hemodialysis patients revealed that emergency department visits and hospitalizations were significantly higher on dialysis days (Monday, Wednesday, Friday) and particularly increased after the long 3-day gap between sessions, indicating a 'dialysis-day effect' and 'interdialytic-gap effect'.

The research also found that rates of ED visits and hospitalizations were lower on weekends, with a notable rise from Sunday to Monday, highlighting a 'post-weekend effect' that suggests a need for further investigation into the causes and potential interventions to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department visits and hospitalizations among hemodialysis patients by day of the week and dialysis schedule in the United States. Zhang, S., Morgenstern, H., Albertus, P., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2468024919315554

Narrative Review of Incremental Hemodialysis Patients may have slow deterioration of kidney function, moving from predialysis CKD to phases of early-stage ESKD when requiring HD initiation; these patients ...

2. scholarlycommons.henryford.com scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1333&context=nephrology_articles

Incremental Hemodialysis: What We Know so Far 33 In a study of 312 patients in China, the health related quality of life tended to be better in the incremental group for the majority of ...

3. ajkd.org ajkd.org/article/S0272-6386(16)00023-8/abstract

Incremental Hemodialysis, Residual Kidney Function, and ... Incremental regimens showed higher mortality risk in patients with inadequate baseline renal urea clearance (≤3.0mL/min/1.73m2; HR, 1.61; 95% CI, 1.07-2.44), ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5733884/

Incremental and Once- to Twice-Weekly Hemodialysis Simple, reliable, and cost-effective criteria for predicting benefit and harm of twice-weekly hemodialysis will help implement an incremental approach in this ...

5. academic.oup.com academic.oup.com/ckj/article/17/1/sfad280/7382238

a systematic review and meta-analysis | Clinical Kidney Journal Incremental HD has been shown to be safe and may provide superior benefits in clinical outcomes, particularly in appropriately selected patients.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40005041/

Review of Clinical Trials Focused on Patients Undergoing ... Items, including age, causes of chronic kidney disease (CKD) ... Conclusions: 1WHD has been shown to be safe and may result in improved clinical ...