Hemodialysis for Chronic Kidney Failure

No longer recruiting at 2 trial locations

Overseen By Saniya Bonde, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Palo Alto Veterans Institute for Research

Must not be taking: Antibiotics

Disqualifiers: Recent hospitalization, Low kidney function, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the effectiveness of hemodialysis twice a week for individuals with some remaining kidney function. Participants will alternate between receiving dialysis twice a week and three times a week to identify the more effective schedule. It is suitable for those who have been on dialysis for at least three months, retain some kidney function, and adhere to their regular treatment schedule. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance dialysis schedules for others.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using antibiotics or expect to use them, you may not be eligible to participate.

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

Research has shown that hemodialysis twice a week can be safe for patients with some remaining kidney function. One study found that patients who switched from three times a week to twice a week maintained stable health without major issues. This suggests that twice-weekly treatment is generally well-tolerated, particularly for those with residual kidney function.

For many years, hemodialysis three times a week has been the standard treatment. Studies have demonstrated its safety and effectiveness in managing kidney failure, with patients typically maintaining stable health.

Both twice-weekly and thrice-weekly hemodialysis are considered safe for individuals with long-term kidney failure. However, the choice between them often depends on the patient's specific condition and the doctor's recommendation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores flexible scheduling for hemodialysis, which could potentially improve the quality of life for people with chronic kidney failure. Typically, patients undergo hemodialysis three times a week. This study investigates alternating between twice and thrice-weekly sessions, offering a chance to balance treatment effectiveness with personal convenience. By examining these different schedules, researchers hope to find more personalized and less burdensome treatment plans for patients.

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

This trial will compare twice-weekly and thrice-weekly hemodialysis schedules. Studies have shown that both schedules can effectively clean waste and water from the blood for patients with some remaining kidney function. Research indicates that twice-weekly dialysis can result in similar levels of inflammation and nutrition as thrice-weekly dialysis. However, some evidence suggests a higher risk of death for patients undergoing dialysis twice a week compared to three times a week. On the positive side, twice-weekly dialysis has been linked to a better quality of life for some patients. Ultimately, the choice between twice or thrice-weekly dialysis may depend on a person's specific health needs and the remaining function of their kidneys. ^{2 3 4 6 7}

Who Is on the Research Team?

Tammy Sirich, MD

Principal Investigator

Stanford/VA Palo Alto Health Care System

Are You a Good Fit for This Trial?

This trial is for stable dialysis patients who can consent to participate. It's not for those who've used antibiotics in the last two months, expect to use them soon, were recently hospitalized, or have very low residual kidney function (<2.5 mL/min).

Inclusion Criteria

Stable dialysis patients able to provide consent

Exclusion Criteria

You have taken antibiotics in the last two months or are expected to take them during the study.

You recently had a hospital stay or another event that made it hard for you to eat regularly.

Your kidneys are not working well, and filter less than 2.5 milliliters of fluid per minute.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two 4-week study periods with twice weekly versus thrice weekly hemodialysis

8 weeks

Twice or thrice weekly visits for hemodialysis

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life and cognitive assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Thrice weekly hemodialysis
• Twice weekly hemodialysis

Trial Overview

The study compares the effectiveness of hemodialysis twice a week versus the standard three times a week in patients who still have some kidney function left.

How Is the Trial Designed?

Group I: Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis Experimental Treatment 1 Intervention

Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.

Group II: Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis Experimental Treatment 1 Intervention

Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

Who Is Running the Clinical Trial?

Palo Alto Veterans Institute for Research

Lead Sponsor

Trials

58

Recruited

8,800+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7253701/

Impact of twice- or three-times-weekly maintenance ...

Twice- and 3-times-weekly MHD resulted in comparable inflammatory and nutritional clinical outcomes and adverse events. QOL was better for the twice-weekly ...

2.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT03415776

NCT03415776 | Twice Against Thrice-weekly Hemodialysis

A large retrospective study from the US showed that incremental hemodialysis compared to conventional hemodialysis (three times per week) improved mortality in ...

3.

journals.lww.com

journals.lww.com/md-journal/fulltext/2016/02150/comparison_of_clinical_outcome_between.29.aspx

Comparison of Clinical Outcome Between Twice-Weekly ...

Our study revealed that patients with RKF undergoing twice-weekly HD had an increased risk for mortality compared with patients with RKF undergoing thrice- ...

4.

academic.oup.com

academic.oup.com/ndt/article/32/2/355/2982347

Comparison of outcomes between the incremental and thrice ...

Conclusions: Incremental HD initiation showed comparable results to thrice-weekly initiation for HRQOL, residual renal function and all-cause ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0272638621010404

Twice-Weekly Hemodialysis With Adjuvant ...

Outcome. The primary outcome was feasibility. Secondary outcomes included changes in urine volume and solute clearance. Results. Of 77 patients ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11972488/

Twice against thrice-weekly hemodialysis (TATH)

This trial aimed to compare the outcomes of patients undergoing twice-weekly versus thrice-weekly hemodialysis.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3338294/

Survival in Daily Home Hemodialysis and Matched Thrice- ...

These data suggest that relative to thrice-weekly in-center hemodialysis, daily home hemodialysis associates with modest improvements in survival.