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

Dialysis Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05936021
• Other study ID #: SMART Study
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anemia
• Dialysis
• Kidney Diseases
• Kidney Failure, Chronic

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