Incremental vs Conventional Hemodialysis for Kidney Failure

Recruiting at 16 trial locations

Overseen By Ruth Stastny

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Queensland

Disqualifiers: Low urine output, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

372 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of hemodialysis (HD) for individuals with kidney failure. The goal is to determine if starting HD with fewer sessions per week and increasing only when necessary can improve quality of life while remaining safe, practical, and cost-effective. Participants will either begin with two HD sessions a week, increasing as needed, or start with the usual three sessions weekly. Individuals who are new to HD treatment and can provide consent may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future dialysis practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that starting dialysis gradually, known as Incremental Hemodialysis (HD), is generally safe. Studies have found that it can lead to good health outcomes, especially for carefully selected patients. This approach might help maintain kidney function better than starting with full dialysis sessions immediately. It is also considered safe for about two-thirds of patients new to dialysis. Overall, Incremental HD is a well-tolerated option for many beginning dialysis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing incremental hemodialysis (HD) with conventional hemodialysis for kidney failure because incremental HD offers a personalized approach. Unlike the standard thrice-weekly sessions in conventional HD, incremental HD starts with just two sessions per week. This gentler approach could potentially reduce the burden on patients and improve their quality of life by adjusting the frequency based on individual needs. If successful, this method might not only be more convenient but also help preserve kidney function longer compared to starting with more frequent sessions right away.

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

In this trial, participants will be randomized to receive either incremental hemodialysis (HD) or conventional HD. Research has shown that starting with fewer dialysis sessions, known as incremental HD, can be as safe as the usual approach and might even lead to better health outcomes for some individuals. Participants in the incremental HD group will start with two treatments a week, increasing if necessary, which can save money while maintaining safety. This approach is particularly beneficial for those who still have some natural kidney function. In contrast, participants in the conventional HD group will begin with three sessions a week immediately. ^{2 3 4 6 7}

Who Is on the Research Team?

Andrea Viecelli, Dr

Principal Investigator

University of Queensland, Queensland Health

Peter Kerr, Prof

Principal Investigator

University of Queensland, Monash University

David Johnson, Prof

Principal Investigator

University of Queensland, Queensland Health

Charmaine Lok, Prof

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

The INCH-HD trial is for adults over 18 who are starting hemodialysis (HD) as their first treatment for kidney failure. They must be able to consent to the study and likely stay on HD for at least a year. People with urine output less than half a liter per day can't join.

Inclusion Criteria

I am starting hemodialysis as my first dialysis treatment.

Able to give informed consent

Exclusion Criteria

Unlikely to have been on hemodialysis for at least 1 year.

You are not producing enough urine each day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either incremental HD (twice weekly) or conventional HD (thrice weekly) based on randomization

6 months

Regular HD sessions as per assigned group

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Monthly assessments

Extension

Continued monitoring and assessment of health-related quality of life and other outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional HD
• Incremental HD

Trial Overview

This trial compares incremental HD, which gradually increases dialysis frequency, with conventional HD that uses a regular schedule from the start. It aims to see if incremental HD better maintains quality of life and is safe and cost-effective.

How Is the Trial Designed?

Group I: Incremental HD Experimental Treatment 1 Intervention

Participants randomised to incremental HD will commence HD twice weekly and continue until an indication for an increase to three sessions/week (trigger point) is reached.

Group II: Conventional HD Experimental Treatment 1 Intervention

Participants randomised to conventional HD will commence HD thrice weekly from the first HD session.

Conventional HD is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Hemodialysis for:

• Acute kidney injury
• Chronic kidney disease
• End-stage renal disease
• Uremic encephalopathy
• Pericarditis
• Life-threatening hyperkalemia
• Refractory acidosis
• Hypervolemia causing end-organ complications

Approved in United States as Hemodialysis for:

• Acute kidney injury
• Chronic kidney disease
• End-stage renal disease
• Uremic encephalopathy
• Pericarditis
• Life-threatening hyperkalemia
• Refractory acidosis
• Hypervolemia causing end-organ complications

Approved in Canada as Hemodialysis for:

• Acute kidney injury
• Chronic kidney disease
• End-stage renal disease
• Uremic encephalopathy
• Pericarditis
• Life-threatening hyperkalemia
• Refractory acidosis
• Hypervolemia causing end-organ complications

Approved in Japan as Hemodialysis for:

• Acute kidney injury
• Chronic kidney disease
• End-stage renal disease
• Uremic encephalopathy
• Pericarditis
• Life-threatening hyperkalemia
• Refractory acidosis
• Hypervolemia causing end-organ complications

Approved in China as Hemodialysis for:

• Acute kidney injury
• Chronic kidney disease
• End-stage renal disease
• Uremic encephalopathy
• Pericarditis
• Life-threatening hyperkalemia
• Refractory acidosis
• Hypervolemia causing end-organ complications

Approved in Switzerland as Hemodialysis for:

• Acute kidney injury
• Chronic kidney disease
• End-stage renal disease
• Uremic encephalopathy
• Pericarditis
• Life-threatening hyperkalemia
• Refractory acidosis
• Hypervolemia causing end-organ complications

Who Is Running the Clinical Trial?

The University of Queensland

Lead Sponsor

Trials

149

Recruited

71,700+

Medical Research Future Fund

Collaborator

Trials

10

Recruited

210,000+

Queensland Health

Collaborator

Trials

5

Recruited

2,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a study of 434 patients on incremental hemodialysis (HD) compared to 50,162 on conventional HD, survival rates were similar, suggesting that starting with an incremental approach does not compromise patient survival for those with low to moderate comorbidities.

However, patients with higher comorbidity (Charlson Comorbidity Index ≥5) showed increased mortality in the incremental HD group, indicating that patient selection is crucial and further clinical trials are needed to assess the safety and effectiveness of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment frequency and mortality among incident hemodialysis patients in the United States comparing incremental with standard and more frequent dialysis. Mathew, A., Obi, Y., Rhee, CM., et al.[2022]

Incremental home hemodialysis allows patients with residual kidney function to safely maintain their urea clearance targets while reducing the frequency of dialysis sessions, which can enhance patient comfort and adherence.

In a study of 5 patients from 2011 to 2015, those on an incremental regimen preserved their kidney function for over 2 years and avoided the need for frequent dialysis sessions, significantly reducing the risk of complications associated with vascular access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incremental short daily home hemodialysis: a case series. Toth-Manikowski, SM., Mullangi, S., Hwang, S., et al.[2018]

This feasibility study will assess the safety and acceptability of a novel incremental hemodialysis regimen over 15 weeks in 20 patients, aiming to improve patient wellbeing and reduce early mortality rates.

The study will compare outcomes such as blood pressure control and quality of life between the incremental group and a historical control group of 40 patients on conventional hemodialysis, providing valuable insights into the effectiveness of this new approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed-method feasibility study of a novel transitional regime of incremental haemodialysis: study design and protocol. Hazara, AM., Allgar, V., Twiddy, M., 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]

A survey of 243 Canadian nephrologists revealed that 65% prescribe incremental hemodialysis based on individual patient needs, indicating a trend towards personalized treatment in kidney care.

Despite a general agreement on the importance of considering residual kidney function in dialysis prescriptions, 74% of nephrologists felt there was insufficient evidence supporting the effectiveness of incremental hemodialysis, highlighting a need for more research to address safety and implementation challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge and Practice of Incremental Hemodialysis: A Survey of Canadian Nephrologists. Dahiya, A., Bello, A., Thompson, S., et al.[2023]

Incremental hemodialysis (HD) allows patients to start with lower frequency treatments, which can be gradually increased, and this approach was shown to be viable for about 1-2 years for 80.7% of patients, leading to significant savings in treatment sessions (45.9%).

The survival rates of patients on incremental HD were comparable to the overall Italian dialysis population, with a gross mortality rate of 12.6%, suggesting that this method is a safe and effective option for new dialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could incremental haemodialysis be a new standard of care? A suggestion from a long-term observational study. Casino, FG., Lopez, T., Santarsia, G., et al.[2022]

Increasing the frequency of hemodialysis from twice to thrice weekly in 569 patients led to better control of pre-dialysis systolic blood pressure, particularly in those with higher baseline blood pressure, showing a decrease of 12 mm Hg.

Patients with higher weekly interdialytic weight gain (IDWG) experienced a decrease in ultrafiltration volume, while those with lower IDWG saw an increase, indicating that treatment frequency adjustments can impact fluid management differently based on individual patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic and Laboratory Changes during Incremental Transition from Twice to Thrice-Weekly Hemodialysis. Hur, I., Wenziger, C., Obi, Y., et al.[2021]

In a study of 709 patients undergoing hemodialysis, those receiving incremental dialysis (254 patients) showed significantly better short-term survival rates compared to those on conventional hemodialysis (455 patients), even after adjusting for various health factors.

Patients on incremental dialysis experienced quicker recovery times post-treatment, likely due to reduced hemodynamic stress from shorter and less intensive dialysis sessions, suggesting a potential benefit of this individualized approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of characteristics of centers practicing incremental vs. conventional approaches to hemodialysis delivery - postdialysis recovery time and patient survival. Davenport, A., Guirguis, A., Almond, M., et al.[2020]

Incremental dialysis, whether through hemodialysis (IHD) or peritoneal dialysis (IPD), helps preserve residual kidney function (RKF) better than full-dose dialysis, resulting in a slower decline of kidney function by about 0.58 ml/min/month.

Patients on incremental dialysis can delay the need for full-dose dialysis by approximately 12.1 months without an increased risk of mortality, suggesting it may be a safer and more effective approach for managing end-stage renal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incremental dialysis in ESRD: systematic review and meta-analysis. Garofalo, C., Borrelli, S., De Stefano, T., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7000841/

Narrative Review of Incremental Hemodialysis - PMC

Patients on HD with higher levels of RKF have generally reported better quality of life, and longer survival than those with lower levels of RKF. Confounding ...

2.

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.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03239808

Incremental Haemodialysis in Incident Patients

... Outcomes in Caring for End-Stage Renal Disease ... Residual renal function improves outcome in incremental haemodialysis despite reduced dialysis dose.

4.

ajkd.org

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

Incremental Hemodialysis, Residual Kidney Function, and ...

... Outcomes in Caring for End-Stage Renal Disease ... Residual renal function improves outcome in incremental haemodialysis despite reduced dialysis dose.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0085253821007493

A multicenter feasibility randomized controlled trial to ...

Incremental hemodialysis appears safe and cost-saving in incident patients with adequate RKF, justifying a definitive trial.

6.

pubmed.ncbi.nlm.nih.gov

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

Review of Clinical Trials Focused on Patients Undergoing ...

1WHD has been shown to be safe and may result in improved clinical outcomes, particularly in appropriately selected patients.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2468024922011895

Incremental and Personalized Hemodialysis Start: A New ...

Our study reveals that iHD can be a new standard of care, as it is safe and feasible in up to two-thirds of patients on incident HD.