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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 range18 Years

SexALL

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.

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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