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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

NCT05936021 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-26

No results posted yet for this study

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.

Conditions

  • Dialysis

Interventions

PROCEDURE

Algorithm model-based Aranesp doses

Patients will receive doses calculated by the algorithm instead of by the standard of care procedures. Model-based Aranesp doses will be computed at the same time that doses based on the dialysis anemia protocol are determined. The model-based doses will be administered instead of the protocol-based doses and in the same way and at the same time as the protocol-based doses would have been. The model-based dosing will be more flexible than the protocol-based dosing. Some constraints in the protocol-based dosing were created to prevent patients from achieving high Hb levels. The model-based dosing will also prevent these high Hb values but will do so by predicting a patient's Hb level into the future and then using these predictions to determine doses to reduce Hb variability and to reduce the amount of Aranesp used.

PROCEDURE

Standard of care

Current standard of care guidelines are followed for erythropoiesis-stimulating agents to control anemia in dialysis patients

Sponsors & Collaborators

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Chemiti Gopal, MD · Intermountain Health Care, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-11-01
Completion
2025-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936021 on ClinicalTrials.gov