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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
Adult Veterans diagnosed with ESRD and who will soon need chronic dialysis initiation or have initiated hemodialysis (HD) not longer than 8 weeks of the target randomization day in one of the six VA centers
Willingness to undergo the randomly assigned modality of 2x/wk vs 3x/wk HD
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 below
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I am a veteran with kidney failure needing dialysis, started less than 8 weeks ago at a VA center.
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I am willing to follow a treatment plan that could be 2 or 3 times a week.
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I am willing to attend all required study tests, in person or via telehealth.
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I agree to monthly reviews and interviews for the study.
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My kidneys produce more than 0.5 liters of urine a day and can filter waste efficiently.

INCHVETS Trial 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
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

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 more
Other 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
1,599 Previous Clinical Trials
3,304,846 Total Patients Enrolled
Kamyar Kalantar-Zadeh, MD PhDPrincipal InvestigatorVA Long Beach Healthcare System, Long Beach, CA

Media Library

Thrice-Weekly Hemodialysis (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05465044 — N/A
Kidney Dysfunction Research Study Groups: Thrice-Weekly Hemodialysis, Twice-Weekly Hemodialysis
Kidney Dysfunction Clinical Trial 2023: Thrice-Weekly Hemodialysis Highlights & Side Effects. Trial Name: NCT05465044 — N/A
Thrice-Weekly Hemodialysis (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05465044 — N/A

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."

Answered by AI
~168 spots leftby Sep 2027