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

NCT05936021 | Active Not Recruiting

• 1 other identifier: SMART Study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Dialysis

Keywords

darbepoetin; kidney; dialysis; hemoglobin cycling

Outcome Measures

Primary Outcomes (2)

• Reduction of hemoglobin cycling in dialysis patients

  Reduction of hemoglobin cycling

  90 days after the intervention

• Time hemoglobin levels are maintained within acceptable range

  Time hemoglobin levels are maintained within acceptable range

  90 days after the intervention

Secondary Outcomes (1)

• Reduction in quantity of drug administered to patients

  90 days after the intervention

Study Arms (2)

Standard of care

OTHER

All patients placed on dialysis receive standard of care

Procedure: Standard of care

Model-based Aranesp doses

EXPERIMENTAL

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

Interventions

Algorithm model-based Aranesp doses PROCEDURE

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.

Model-based Aranesp doses

Standard of care PROCEDURE

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

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females (≥ 18 years of age) with End Stage Kidney Disease undergoing in-center hemodialysis
• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (2)

Intermountain Kidney Clinic

Murray, Utah, 84017, United States

Location

Dialysis Services

Murray, Utah, 84107, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Chemiti Gopal, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 7, 2023
• Study Start: July 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

US (2)