Hemodialysis for Chronic Kidney Failure

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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.

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 hemodialysis safe for humans?

Research suggests that both twice-weekly and thrice-weekly hemodialysis are generally safe for people with kidney failure. Studies indicate that starting with fewer sessions per week can be safe and may help preserve remaining kidney function. ^{1 2 3 4 5}

How does twice-weekly hemodialysis differ from other treatments for chronic kidney failure?

Twice-weekly hemodialysis is unique because it is an incremental approach that starts with fewer sessions per week, which can help preserve the remaining kidney function in patients who still have some kidney activity. This contrasts with the more common thrice-weekly schedule, which is often used regardless of the patient's residual kidney function. ^{3 4 5 6 7}

What data supports the effectiveness of the treatment Thrice weekly hemodialysis, Twice weekly hemodialysis for Chronic Kidney Failure?

Research suggests that starting with twice-weekly hemodialysis can help preserve remaining kidney function in patients who still have some kidney activity, which may improve survival and quality of life. This approach is especially considered for patients with significant residual kidney function, as it may slow down the decline of kidney function compared to more frequent dialysis. ^{3 4 6 7 8}

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 Experimental Treatment 1 Intervention

Participants will undergo hemodialysis twice per week.

Group II: Thrice weekly hemodialysis Experimental Treatment 1 Intervention

Participants will undergo hemodialysis three times per week.

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 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]

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]

Citations

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

Infrequent dialysis: a new paradigm for hemodialysis initiation. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Twice-Weekly Hemodialysis in China: Can It Be A Better Option for Initiation or Maintenance Dialysis Therapy? [2018]

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

Incremental Hemodialysis: The University of California Irvine Experience. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Initiating haemodialysis twice-weekly as part of an incremental programme may protect residual kidney function. [2020]

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

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

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Outcome of Twice-Weekly Hemodialysis Patients with Long-Term Dialysis Vintage. [2018]