Incremental Hemodialysis for Chronic Kidney Disease (INCHVETS Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
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.
Is Thrice-Weekly Hemodialysis, with a gradual increase from Twice-Weekly Hemodialysis, a promising treatment for chronic kidney disease?Yes, this treatment approach is promising because it can be more patient-friendly and less burdensome. It allows for a gradual start, which can help ease patients into the treatment and may help preserve their remaining kidney function for a longer time. This method also considers the patient's quality of life, making it a more personalized treatment option.24567
What safety data is available for incremental hemodialysis?The safety of incremental hemodialysis, which includes starting with less frequent sessions and transitioning to thrice-weekly hemodialysis, has been explored in several studies. A pilot study assessed the feasibility and safety of this approach, suggesting it is a viable option. Incremental hemodialysis is considered safe and less burdensome, with potential benefits such as preserving residual kidney function and improving quality of life. However, there are no established guidelines, and practices vary across different settings. A systematic review compared twice to thrice-weekly hemodialysis, indicating interest in less frequent schedules. Overall, while incremental hemodialysis shows promise, more research is needed to establish comprehensive safety data.34567
What data supports the idea that Incremental Hemodialysis for Chronic Kidney Disease is an effective treatment?The available research shows that Incremental Hemodialysis, which includes starting with fewer sessions per week, can be effective for patients with some remaining kidney function. It can help ease patients into the treatment, making it more comfortable and potentially preserving kidney function longer. This approach is also more patient-friendly and can improve quality of life compared to the standard thrice-weekly schedule. While there are no strict guidelines, the practice has been successfully implemented in places like Le Mans, where many patients start with this incremental approach.12456
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the study staff or your healthcare provider.
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
My kidneys produce more than 0.5 liters of urine a day and can filter waste efficiently.
Exclusion Criteria
I have a terminal illness and am expected to live less than 6 months.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Twice-Weekly HemodialysisExperimental Treatment1 Intervention
Twice-weekly hemodialysis with incremental crossover to thrice-weekly hemodialysis as indicated
Group II: Thrice-Weekly HemodialysisPlacebo Group1 Intervention
Outright thrice-weekly hemodialysis without option to switch to less frequent dialysis schedule
Thrice-Weekly Hemodialysis is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Hemodialysis for:
- End-stage renal disease (ESRD)
- Chronic kidney disease
🇪🇺 Approved in European Union as Hemodialysis for:
- End-stage renal disease (ESRD)
- Chronic kidney disease
🇨🇦 Approved in Canada as Hemodialysis for:
- End-stage renal disease (ESRD)
- Chronic kidney disease
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NYNew York, NY
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest Haven, CT
Memphis VA Medical Center, Memphis, TNMemphis, TN
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, CA
More Trial Locations
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
References
Patient quality of life on quotidian hemodialysis. [2022]Studies have shown improved quality of life for hemodialysis (HD) patients after changing from conventional thrice-weekly HD treatment to more frequent HD.
What Is Known and Unknown About Twice-Weekly Hemodialysis. [2018]The 2006 Kidney Disease Outcomes Quality Initiative guidelines suggest twice-weekly or incremental hemodialysis for patients with substantial residual kidney function (RKF). However, in most affluent nations de novo and abrupt transition to thrice-weekly hemodialysis is routinely prescribed for all dialysis-naïve patients regardless of their RKF. We review historical developments in hemodialysis therapy initiation and revisit twice-weekly hemodialysis as an individualized, incremental treatment especially upon first transitioning to hemodialysis therapy.
Emergency department visits and hospitalizations among hemodialysis patients by day of the week and dialysis schedule in the United States. [2020]Previous reports indicated that patients on thrice-weekly hemodialysis (HD) had higher mortality rates after the 3-day interdialytic interval. However, day-of-the-week patterns of emergency department (ED) visits and hospitalizations remain under-investigated.
Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study. [2023]Thrice-weekly hemodialysis (HD) is the most common treatment modality for kidney failure in the United States. We conducted a pilot study to assess the feasibility and safety of incremental-start HD in patients beginning maintenance HD.
Twice versus thrice weekly hemodialysis: A systematic review. [2022]Thrice weekly hemodialysis (HD) is currently the norm in high income countries but there is mounting interest in twice weekly HD in certain settings. We performed this systematic review to summarize the available evidence comparing twice to thrice weekly HD.
The ABCs of personalized incremental dialysis start, Le Mans style. [2023]Thrice weekly hemodialysis (HD) is considered the standard of care for patients with end-stage chronic kidney disease (CKD) on extracorporeal renal replacement therapy. However, recent evidence has shown that up to one third of patients start dialysis with a residual kidney function that could allow a reduced frequency/dialysis dose. Interest towards HD schedules other than thrice weekly and the lessons learned from peritoneal dialysis, in addition to growing attention to patients' quality of life, have promoted renewed attention towards incremental HD (iHD). iHD comprises once and twice weekly schedules, makes it possible to soften the "dialysis shock" at the inception of therapy and is patient-friendly. Moreover, it might contribute to preserving residual kidney function longer. Nevertheless, iHD is performed differently in different settings and no guidelines exist on this subject. Taking advantage of the experience accrued with regard to the treatment of advanced CKD both in the outpatient clinic and in the dialysis unit in Le Mans, where two thirds of incident HD patients start in an incremental way, we aimed to present the practical aspects of iHD and discuss its advantages and drawbacks.
Australian Workshops on Patients' Perspectives on Hemodialysis and Incremental Start. [2023]Most patients with kidney failure commence and continue hemodialysis (HD) thrice weekly. Incremental initiation (defined as HD less than thrice weekly) is increasingly considered to be safe and less burdensome, but little is known about patients' perspectives. We aimed to describe patients' priorities and concerns regarding incremental HD.