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Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial

NCT03214627 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-01-07

No results posted yet for this study

Summary

Fresenius Medical Care has developed a computer software programme called the Anaemia Control Management (ACM) software to assist in the anaemia management of patients with chronic kidney disease (CKD) undergoing hemodialysis. This trial is designed to assess the effectiveness of this ACM software on anaemia management in routine clinical practice. However, all ultimate decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the discretion of the Investigator. The trial consists of a retrospective (historical) control period and a prospective (going forward) period. During the prospective period, the ACM will be used to assist the Investigators' decision making and will help the Investigators to administer a personalised intravenous (IV) iron and red blood cell stimulating agent (ESA) therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective period of the trial. Thus, patients can serve as their own control.

Conditions

Interventions

DEVICE

Anemia Control Model (ACM)

The ACM is mainly composed of 2 sub-Systems - predictor model which, depending on the input data, forecasts the response to anaemia drug therapy for a specific patient. The predictor model is implemented as a feed-forward artificial neural network. The ACM is an algorithm that extracts the optimal policy to achieve the established clinical outcome for anaemia management using the predictor model.

DRUG

IV iron

IV iron given monthly as required - dose determined by the ACM and as agreed by the investigator

DRUG

Erythropoiesis-Stimulating Agent (ESA)

ESA given monthly as required over 6 months - dose determined by the ACM and as agreed by the investigator

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Fresenius Medical Care Deutschland GmbH

    collaborator INDUSTRY

  • Vifor Fresenius Medical Care Renal Pharma

    lead INDUSTRY

Principal Investigators

  • Iain Macdougall · King's College Hospital NHS Trust

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2019-05-21
Completion
2019-05-21

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03214627 on ClinicalTrials.gov