Incremental Hemodialysis Frequency for Kidney Failure

Recruiting at 14 trial locations

Overseen By Ben Bagwell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Pregnancy, High potassium, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if starting hemodialysis less frequently can match the effectiveness of the traditional three-times-a-week schedule for individuals with new kidney failure. It will compare two groups: one following the standard schedule (Conventional Hemodialysis) and another using a personalized schedule (Incremental Hemodialysis) based on the patient's remaining kidney function. This approach may suit those who have recently begun dialysis and retain some natural kidney function. As an unphased trial, this study provides an opportunity to explore a potentially more convenient treatment option tailored to individual kidney function.

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, tailored to a patient's kidney function, is generally safe for most people. Studies have found that this method is well-tolerated and might even offer health benefits, especially for carefully selected patients. This approach customizes treatment to fit the patient's needs without compromising safety.

One analysis suggested that this method could become a new standard of care because it is both safe and practical for many beginning dialysis. No major negative effects have been specifically linked to this approach, indicating it is a dependable option for managing kidney failure.

For those considering joining a clinical trial, these findings are reassuring. Incremental hemodialysis appears to be a promising and safe alternative to the usual method of three sessions per week. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores Incremental Hemodialysis as a potential game-changer for managing kidney failure. Unlike the standard practice of administering hemodialysis three times a week, Incremental Hemodialysis starts with a less frequent, twice-weekly session. This approach tailors treatment based on a patient's remaining kidney function and clinical symptoms, potentially reducing the burden of dialysis sessions. The hope is that this personalized method could improve quality of life while still effectively managing kidney failure.

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

This trial will compare Conventional Hemodialysis (CHD) with Clinically-matched Incremental Hemodialysis (CMIHD). Research has shown that incremental hemodialysis, which adjusts treatment based on remaining kidney function, may surpass regular hemodialysis. Studies have found it safe and potentially more beneficial for certain patient outcomes. Specifically, patients with more remaining kidney function on this treatment reported a better quality of life and longer survival. A review of multiple studies found that it might lead to better health results in carefully chosen patients. These findings suggest that incremental hemodialysis could be an effective option for those starting dialysis. ^{2 3 5 6 7}

Who Is on the Research Team?

Mariana Murea, MD

Principal Investigator

Wake Forest Health Sciences

Peter Kotanko

Principal Investigator

Renal Research Institute

Are You a Good Fit for This Trial?

Adults over 18 with new-onset kidney dysfunction requiring dialysis can join this trial. They should have started or be starting in-center hemodialysis soon, and not been on it for more than 6 weeks. Participants need some remaining kidney function and urine output. Those with certain blood chemistry imbalances, high fluid removal needs, a short life expectancy, or pregnancy are excluded.

Inclusion Criteria

I am on or will start dialysis soon due to kidney problems.

I have had 18 or fewer dialysis sessions over 6 weeks or less.

Your kidney function is not working very well.

Exclusion Criteria

You need or may need a lot of fluid removed from your blood.

Your blood test shows high potassium, low sodium, or low bicarbonate levels before the study.

I am unable to follow or unwilling to commit to the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either incremental hemodialysis or conventional hemodialysis

2 years

Regular visits as per hemodialysis schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Caregiver Follow-up

Caregivers are followed along with patients to assess caregiver burden and quality of life

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Hemodialysis
• Hemodialysis thrice weekly
• Hemodialysis twice weekly
• Incremental Hemodialysis

Trial Overview The TwoPlus Trial is comparing two schedules of hemodialysis for people with kidney failure: one group will receive treatments twice a week while the other will have them three times a week. The goal is to see which frequency is better when patients still have some kidney function left.

How Is the Trial Designed?

Group I: Clinically-matched Incremental Hemodialysis ( CMIHD) Experimental Treatment 1 Intervention

Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly.

Group II: Conventional Hemodialysis (CHD) Active Control 1 Intervention

Randomized group to conventional three times a week hemodialysis.

Conventional Hemodialysis is already approved in United States, European Union for the following indications:

Approved in United States as Conventional Hemodialysis for:

• End-stage kidney disease
• Chronic kidney disease progressing to dialysis-dependent kidney disease

Approved in European Union as Conventional Hemodialysis for:

• End-stage kidney disease
• Chronic kidney disease progressing to dialysis-dependent kidney disease

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

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]

Recent studies suggest that more frequent daily hemodialysis may improve intermediate patient outcomes such as blood pressure control, anemia, and quality of life, which could be linked to better survival rates in dialysis patients.

Despite promising findings, current studies are small and lack the power to definitively prove that daily hemodialysis reduces mortality and morbidity, and no randomized controlled trials have been reported yet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is more frequent hemodialysis beneficial and what is the evidence? Lindsay, RM., Nesrallah, G., Suri, R., et al.[2019]

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 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]

Conventional thrice weekly hemodialysis has not led to significant improvements in clinical outcomes for patients, indicating a need for alternative treatment approaches.

More intensive hemodialysis regimens, such as daily short dialysis and nocturnal prolonged dialysis, show potential for reducing morbidity and mortality, suggesting they may be more effective options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More intensive hemodialysis. Kliger, AS.[2009]

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]

Incremental haemodialysis initiation, which involves fewer sessions or shorter durations than standard treatment, does not increase the risk of mortality compared to the standard 4-hour thrice-weekly approach, based on a systematic review of 26 studies with a total of 101,476 participants.

The review suggests that incremental haemodialysis may lead to reduced hospitalization rates and lower treatment costs, although evidence on quality of life and other adverse events is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of incremental initiation of haemodialysis on mortality: a systematic review and meta-analysis. Caton, E., Sharma, S., Vilar, E., 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]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03239808

Incremental Haemodialysis in Incident Patients Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities.

3. 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.

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

Incremental Hemodialysis, Residual Kidney Function, and ... Compared with 8,068 patients with conventional hemodialysis regimens matched based on baseline renal urea clearance, urine volume, age, sex, diabetes, and ...

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

Narrative Review of Incremental Hemodialysis This review discusses potential benefits of and barriers to alternative dialysis regimens in patients with incident ESKD, with emphasis on twice-weekly HD with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9091804/

Incremental and Personalized Hemodialysis Start The aim of this study was to evaluate mortality, morbidity, and costs in a large HD ward where iHD is the standard of HD start.

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.