Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05936021
Study type Interventional
Source Intermountain Health Care, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date July 1, 2023
Completion date January 1, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05031013 - Trace Elements Concentration in Dialysis
Not yet recruiting NCT03090828 - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease N/A
Completed NCT01685372 - Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults Phase 2
Active, not recruiting NCT01394770 - Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients Phase 4
Completed NCT00506441 - A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia Phase 3
Completed NCT00537979 - Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis Phase 4
Completed NCT05415969 - CKD-aP Among Adults on Dialysis in Switzerland
Recruiting NCT04024007 - Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits
Completed NCT03772171 - Estimate for Dietary Intakes and Hemodialysis Patients
Recruiting NCT02586402 - Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis Phase 2
Active, not recruiting NCT01693263 - Outcome of BCF Access in Hemodialysis Patients
Completed NCT01421771 - Blood Pressure in Dialysis Patients N/A
Active, not recruiting NCT01065389 - Resistance Training in Intradialysis Patients Phase 2
Completed NCT00544492 - Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients Phase 4
Completed NCT03910426 - Prognostic Determinants of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients
Completed NCT04667741 - Post-dialysis Recovery Time and Affecting Factors Between Turkey and Portugal
Completed NCT04565522 - Transmission of COVID-19 Virus Among Patients and Staff in Dialysis Centers
Completed NCT04655989 - A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System N/A
Completed NCT05125848 - Clinical Evaluation of the CM-1500 During Hemodialysis N/A
Completed NCT04633915 - Antibody Response in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.