Incremental Hemodialysis for Chronic Kidney Disease

(INCHVETS Trial)

Recruiting at 5 trial locations

Overseen By Kamyar Kalantar-Zadeh, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Terminal illness, High potassium, others

Trial Summary

What is the purpose of this trial?

This trial tests if starting dialysis less frequently and increasing it gradually is safe and effective for Veterans with kidney disease. It aims to see if this approach can improve quality of life and preserve kidney function longer compared to the usual dialysis schedule. The study could also help reduce costs and keep more patients in VA clinics.

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.

What data supports the effectiveness of the treatment Incremental Hemodialysis for Chronic Kidney Disease?

Research suggests that starting with twice-weekly hemodialysis (a process to clean the blood when kidneys are not working well) and gradually increasing to thrice-weekly can be beneficial for patients with some remaining kidney function. This approach may help preserve kidney function longer and improve quality of life by reducing the initial 'dialysis shock'. ^{1 2 3 4 5}

Is incremental hemodialysis safe for humans?

Incremental hemodialysis, which starts with fewer sessions per week and gradually increases, is considered safe and less burdensome for patients with kidney failure. It may help preserve remaining kidney function longer and is generally well-tolerated, although practices vary and no specific guidelines exist. ^{1 2 3 6 7}

How is incremental hemodialysis different from other treatments for chronic kidney disease?

Incremental hemodialysis starts with fewer sessions per week (once or twice) and gradually increases to the standard thrice-weekly schedule, which can help preserve remaining kidney function and improve quality of life by reducing the initial 'dialysis shock'. ^{1 2 3 4 6}

Research Team

Kamyar Kalantar-Zadeh, MD PhD

Principal Investigator

VA Long Beach Healthcare System, Long Beach, CA

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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 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]

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]

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 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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Twice versus thrice weekly hemodialysis: A systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

The ABCs of personalized incremental dialysis start, Le Mans style. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

What Is Known and Unknown About Twice-Weekly Hemodialysis. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic Hemodialysis Therapy in the West. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Australian Workshops on Patients' Perspectives on Hemodialysis and Incremental Start. [2023]

7. United States 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. [2020]