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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
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
Awards & highlights
INCHVETS Trial Summary
This trial will study whether starting dialysis less frequently is safe and effective, and if it can help Veterans and their care-partners to better cope with dialysis.
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.Check my eligibility
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.See study design
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.
INCHVETS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys produce more than 0.5 liters of urine a day and can filter waste efficiently.
INCHVETS Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change over time in numeric scale of Health-Related Quality of Life (HRQOL) Physical Component Score (PCS) of SF36 questionnaire.
Secondary outcome measures
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 moreOther outcome measures
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)
INCHVETS 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
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,032 Total Patients Enrolled
Kamyar Kalantar-Zadeh, MD PhDPrincipal InvestigatorVA Long Beach Healthcare System, Long Beach, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood potassium level was too high in the month before the study.I am willing to attend all required study tests, in person or via telehealth.I am willing to follow a treatment plan that could be 2 or 3 times a week.I agree to monthly reviews and interviews for the study.I am a veteran with kidney failure needing dialysis, started less than 8 weeks ago at a VA center.You meet the specific requirements listed in Table 4 of the IncHVets Study Protocol for starting incremental dialysis.My kidneys produce more than 0.5 liters of urine a day and can filter waste efficiently.I have a terminal illness and am expected to live less than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Twice-Weekly Hemodialysis
- Group 2: Thrice-Weekly Hemodialysis
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies within this clinical experiment?
"As per data hosted on clinicaltrials.gov, this research programme is not currently recruiting participants. The project was first launched in April of 2023 and the last update occurred at the end of October 2022. Nonetheless, there are nearly 500 other medical studies that presently require volunteers."
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