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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05936021
Other study ID # SMART Study
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date January 1, 2025

Study information

Verified date February 2024
Source Intermountain Health Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Hemoglobin cycling is an outcome of treating long-term dialysis patients for anemia using erythropoiesis-stimulating agents (ESAs), and represents a conundrum for practitioners. While patients with low hemoglobin levels suffer from anemia, high hemoglobin levels may lead to blood clots and subsequent health risks. The current protocol for ESA dosing often results in suboptimal dosing that leads to hemoglobin cycling, which can have a negative impact on patient survival. To this end, we have developed a personalized method for ESA dosing that controls anemia in dialysis patients that is similar to the commercial product sold by PhySoft. Our method, the Dialysis Anemia Treatment Model, uses a mathematical model for erythropoiesis that takes each patient's physiology into account, predicting the optimal dose of ESA for that patient to prevent hemoglobin cycling. The goal of this computer-aided approach is to reduce hemoglobin cycling and the amount of drug used by predicting optimal doses to keep the patient's hemoglobin within the desired range. This is a human subject research study to validate the model in the clinic and demonstrate that it is able to minimize hemoglobin cycling in patients and reduce the amount of ESA drug administered.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date January 1, 2025
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Dialysis Services Murray Utah
United States Intermountain Kidney Clinic Murray Utah

Sponsors (1)

Lead Sponsor Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of hemoglobin cycling in dialysis patients Reduction of hemoglobin cycling 90 days after the intervention
Primary Time hemoglobin levels are maintained within acceptable range Time hemoglobin levels are maintained within acceptable range 90 days after the intervention
Secondary Reduction in quantity of drug administered to patients Reduction in quantity of drug administered to patients 90 days after the intervention
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