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New treatment option for Chronic Kidney Disease (CKD) Stage 5
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
- In this pragmatic clinical trial, which will dovetail with Veterans' routine outpatient dialysis clinic visits in six VA medical centers, the investigators will study 252 Veterans with kidney disease who need to start dialysis treatment. If a Veteran is eligible for the study by making enough residual urine, he/she will have a 50% chance to be offered the usual three-times-per-week dialysis vs.
- 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/wk vs 3x/wk 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 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/wk vs 3x/wk 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 and urea clearance (KRU) \>3 ml/min and meet 5 or more of the 9 other...
- 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 during the 4 weeks prior to the study start.
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- West Los Angeles, California, United States
- West Haven, Connecticut, 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 - 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?
Study sites include Long Beach, California, United States; West Los Angeles, California, United States; West Haven, Connecticut, United States; Albuquerque, New Mexico, United States; New York, New York, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.