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

Sponsor

Intermountain Health Care, Inc. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05936021

Collaborator

(none)

Enrollment

Locations

Arms

18.1

Anticipated Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dialysis	Procedure: Algorithm model-based Aranesp doses Procedure: Standard of care	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

All patients placed on dialysis receive standard of care for a minimum of 150 days; after qualifying for the study, they enter the experimental intervention arm.All patients placed on dialysis receive standard of care for a minimum of 150 days; after qualifying for the study, they enter the experimental intervention arm.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard of care All patients placed on dialysis receive standard of care	Procedure: Standard of care Current standard of care guidelines are followed for erythropoiesis-stimulating agents to control anemia in dialysis patients
Experimental: Model-based Aranesp doses On entering the study cohort, patients will begin receiving 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.	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.

Arm

Intervention/Treatment

Other: Standard of care

All patients placed on dialysis receive standard of care

Procedure: Standard of care

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

Experimental: Model-based Aranesp doses

On entering the study cohort, patients will begin receiving 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.

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.

Outcome Measures

Primary Outcome Measures

Reduction of hemoglobin cycling in dialysis patients [90 days after the intervention]
Reduction of hemoglobin cycling
Time hemoglobin levels are maintained within acceptable range [90 days after the intervention]
Time hemoglobin levels are maintained within acceptable range

Secondary Outcome Measures

Reduction in quantity of drug administered to patients [90 days after the intervention]
Reduction in quantity of drug administered to patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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