Clinical trial NCT05936021: Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease Using the Dialysis Anemia TReatmenT Model
Official title: Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease Using the Dialysis Anemia TReatmenT Model
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dialysis
Keywords: darbepoetin
kidney
dialysis
hemoglobin cycling
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of hemoglobin cycling in dialysis patients
timeFrame: 90 days after the intervention
measure: Time hemoglobin levels are maintained within acceptable range
timeFrame: 90 days after the intervention
Secondary outcomes:
measure: Reduction in quantity of drug administered to patients
timeFrame: 90 days after the intervention
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Kidney Clinic
state: Utah
city: Murray
country: United States
facility: Dialysis Services
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Chemiti Gopal, MD
role: PRINCIPAL_INVESTIGATOR
References: