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Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease Using the Dialysis Anemia TReatmenT Model

United States80 participantsStarted 2023-07-01

Plain-language summary

This is a human subject research study conducted in patients undergoing dialysis treatment with darbepoetin alfa at Intermountain Utah Dialysis and Intermountain Medical Center Dialysis Services. The purpose is to test a dose recommendation algorithm that may reduce hemoglobin variability and drug cost.

Who can participate

Age range

18 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: * Males and females (≥ 18 years of age) with End Stage Kidney Disease undergoing in-center hemodialysis * 150 days of hemoglobin readings and Aranesp doses without a hospitalization relevant to the condition of anemia Exclusion Criteria: * Inflammation as characterized by ferritin levels greater than 1000 ng/mL * Patients with active cancer * Patients with PTH greater than 1,000 pg/mL * Active GI Bleed * Hospitalization relevant to ESRD in last 150 days or during study * Patients receiving Procrit rather than Aranesp.

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

Reduction of hemoglobin cycling in dialysis patients

Timeframe: 90 days after the intervention

Time hemoglobin levels are maintained within acceptable range

Timeframe: 90 days after the intervention

Trial details

NCT IDNCT05936021

SponsorIntermountain Health Care, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

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