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

Status unconfirmed · Not applicable

Conditions studied: Dialysis

In brief

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.

Key facts

Study ID

NCT05936021

Run by

Intermountain Health Care, Inc.

People needed

80

Starts

2023-07-01

Expected to finish

2025-01-01

Last updated by the study team

2024-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Intermountain Kidney Clinic — Murray, Utah, United States
• Dialysis Services — Murray, Utah, United States

Full record on ClinicalTrials.gov

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