What side effects are associated with this type of intervention?

Common treatments for kidney dysfunction, particularly dialysis, include hemodialysis and peritoneal dialysis. Hemodialysis can lead to side effects such as low blood pressure, muscle cramps, itching, sleep problems, anemia, bone diseases, and fluid overload. Peritoneal dialysis may cause infections like peritonitis, hernias, weight gain, and high blood sugar levels. Incremental dialysis, which starts with less frequent sessions and gradually increases, aims to maintain residual kidney function longer and improve quality of life, but it still carries risks similar to standard dialysis, including infection and cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney dysfunction, particularly focusing on dialysis and related therapies. Traditional hemodialysis, performed three times a week, is a standard treatment. Incremental dialysis, which starts with less frequent sessions and gradually increases, is being studied for its potential benefits. While specific FDA approvals for incremental dialysis are not detailed, the approach aligns with existing hemodialysis protocols. Additionally, drugs like erythropoiesis-stimulating agents (e.g., epoetin alfa) and phosphate binders (e.g., sevelamer) are commonly used to manage complications associated with kidney dysfunction in dialysis patients.

What other types of research exist?

Promising novel alternatives to Incremental Dialysis for kidney dysfunction patients include: 1) Home hemodialysis, which allows for more frequent and flexible dialysis sessions, potentially improving quality of life and clinical outcomes. 2) Peritoneal dialysis, which can be performed at home and offers continuous treatment, reducing the burden on the cardiovascular system. 3) Wearable artificial kidneys, which are in development and aim to provide continuous dialysis, improving mobility and lifestyle. 4) Advances in renal transplantation techniques and immunosuppressive therapies, which offer a more permanent solution to kidney dysfunction.

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Procedure

Incremental Hemodialysis for Chronic Kidney Disease (INCHVETS Trial)

N/A

Recruiting

Led By Kamyar Kalantar-Zadeh, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible subjects must have a urine output >0.5 L/day and urea clearance (KRU) >3 ml/min and meet 5 or more of the 9 other incremental dialysis criteria, which are derived from the 2014 Incremental Dialysis Consensus paper (Kalantar-Zadeh et al. Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy. Am J Kidney Dis. 2014 Aug;64(2):181-6. doi: 10.1053/j.ajkd.2014.04.019. PMID: 24840669 PMCID: PMC4111970)

Be older than 18 years old

Must not have

Having a terminal illness with a life expectancy less than 6 months such as stage 4 metastatic cancer or having signed for hospice with life expectancy less than 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change over 12 months based on measuring at baseline and at month 6, and 12 in the sub-study of 112 participants

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't detailed here, dialysis can cause low blood pressure, muscle cramps, itching, sleep problems, anemia and infection risks due to vascular access used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidneys produce more than 0.5 liters of urine a day and can filter waste efficiently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a terminal illness and am expected to live less than 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change over 12 months based on measuring at baseline and at month 6, and 12 in the sub-study of 112 participants

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change over 12 months based on measuring at baseline and at month 6, and 12 in the sub-study of 112 participants

This trial's timeline: 3 weeks for screening, Varies for treatment, and change over 12 months based on measuring at baseline and at month 6, and 12 in the sub-study of 112 participants for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change over time in numeric scale of Health-Related Quality of Life (HRQOL) Physical Component Score (PCS) of SF36 questionnaire.

Secondary study objectives

Change over time in Serum level of Growth Differentiation Factor 15 (GDF15)

Change over time in in numeric score of Dialysis Symptom Index (DSI)

Change over time in numeric scale of Malnutrition-Inflammation Score (MIS)

+3 more

Other study objectives

Change over time in Left Ventricular (LV) mass

Change over time in mid-arm muscle circumference (MAMC) in cm

Change over time in numeric scale of Short Physical Performance Battery (SPPB)

Trial Design

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for kidney dysfunction include hemodialysis and peritoneal dialysis. Hemodialysis works by filtering waste products and excess fluids from the blood through a dialyzer, effectively performing the function of the kidneys. Peritoneal dialysis uses the lining of the abdomen (peritoneum) as a natural filter to clear waste and extra fluid. Incremental dialysis, which starts with less frequent sessions and gradually increases, aims to preserve residual kidney function and improve patient quality of life by reducing the initial burden of frequent dialysis. This approach is significant for kidney dysfunction patients as it can help maintain better overall health, reduce complications, and potentially extend the lifespan of residual kidney function.

Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative.Limited reduction in uremic solute concentrations with increased dialysis frequency and time in the Frequent Hemodialysis Network Daily Trial.Dialysis adequacy today: a European perspective.