Not Yet RecruitingNot Applicable

The Reducing Adverse Outcomes in Dialysis by Adjusting the pRescription for Dialysate Potassium Trial

120 participantsStarted 2025-08-01

Plain-language summary

This will be a randomized controlled pilot trial comparing usual care to a precision approach to dialysis potassium prescribing. The precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD).

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Undergoing in-center, 3x/weekly HD for treatment of end-stage kidney disease (ESKD) for at least 90 days * Age at least 21 years * Prescribed HD time up to 15 hours/ week Exclusion Criteria: * Incarcerated * Life expectancy of 1 year or less * Kidney transplant, transition to home dialysis, or transfer to non-participating HD unit anticipated within 6 months or less * Cognitive condition that precludes consent * Severe anemia (hemoglobin \< 8.0 g/dL) within 30 days * K concentration of 7.0 mEq/L or more within 60 days * Pregnant women * Women of childbearing potential actively trying to conceive unwilling to use contraception * Participation in other interventional studies within 30 days prior to enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intervention Adherence

Timeframe: Up to Week 24

Recruitment Feasibility

Timeframe: Baseline

Incidence Rate of Pre-HD Hyperkalemia

Timeframe: Baseline

Post-HD Recovery Time

Timeframe: Up to Week 24

Trial details

NCT IDNCT07051447

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02-01

Contact for this trial

David Charytan, MD

212-263-0705 David.Charytan@nyulangone.org

View on ClinicalTrials.gov More End Stage Kidney Disease trials