Chronic Kidney Disease (CKD) Stage 5 study: Thrice-Weekly Hemodialysis
Official title Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
ClinicalTrials.gov ID: NCT05465044
What this study is testing
- What it's testing
- The study compares quality of life, kidney function, and safety between veterans who start dialysis twice a week and those who start three times a week.
- Who it's for
- Veterans with stage 5 chronic kidney disease who need dialysis and still produce enough urine to qualify for the study.
- What's involved
- Participants will receive either the usual three times a week dialysis or start with twice a week and increase to three times a week over a year, with regular clinic visits and health assessments.
- Time commitment
- The study lasts one year, with routine outpatient dialysis visits and follow‑up assessments scheduled throughout that period.
- Time commitment: about 12 months
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult Veterans diagnosed with ESRD and who will soon need chronic dialysis initiation or have initiated hemodialysis (HD) not longer than 8 weeks of...
- Meeting the incremental dialysis eligibility criteria in Table 4\ under the IncHVets Study Protocol
- Willingness to undergo the randomly assigned modality of 2x/week vs. 3x/week HD
- Willingness to attend the baseline and quarterly study tests in the dialysis unit or via telehealth as determined by study staff, which will mostly...
- Agreeable to receive monthly or more frequent reviews for and interviews, regardless of being assigned to the incremental or conventional dialysis...
You likely can't join if
- 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...
- A serum potassium level \>6.0 mEq/L (milliequivalents per liter) during the 4 weeks prior to the study start
See the full eligibility criteria
- 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
- Meeting the incremental dialysis eligibility criteria in Table 4\ under the IncHVets Study Protocol
- Willingness to undergo the randomly assigned modality of 2x/week vs. 3x/week HD
- Willingness to attend the baseline and quarterly study tests in the dialysis unit or via telehealth as determined by study staff, which will mostly be parallel to the routine dialysis clinic visits
- Agreeable to receive monthly or more frequent reviews for and interviews, regardless of being assigned to the incremental or conventional dialysis group
- As shown in Table 4 of the INCHVETS Study protocol under incremental dialysis criteria, eligible people must have a urine output \>0.5 L/day (liters per day) and urea clearance (KRU) \>3 ml/min (milliliters per minute)...
- 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
- A serum potassium level \>6.0 mEq/L (milliequivalents per liter) during the 4 weeks prior to the study start
The study team makes the final eligibility decision.
Where it is enrolling
- Long Beach, California, United States
- West Los Angeles, California, United States
- West Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Long Beach, California, United States; West Los Angeles, California, United States; West Haven, Connecticut, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; Albuquerque, New Mexico, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.