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

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ClinicalTrials.gov Identifier: NCT03214627
Recruitment Status : Terminated (Standard clinical practice at site caused unforeseen issues for the use of the ACM)
First Posted : July 11, 2017
Last Update Posted : January 7, 2020
Sponsor:
Collaborators:
Worldwide Clinical Trials
Fresenius Medical Care Deutschland GmbH
Information provided by (Responsible Party):
Vifor Fresenius Medical Care Renal Pharma

Tracking Information
First Submitted Date  ICMJE July 5, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE December 10, 2018
Actual Primary Completion Date May 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2017)
Change in the proportion of patients with haemoglobin within the target range as compared to the historical control period (non-inferiority testing) [ Time Frame: Month -6 to Month -1 compared with Month +1 to Month +6 ]
The proportion of patients with at least 5 (standard of care, approximately monthly) Hb measurements and with 80% of these measurements within the target range of 10 to 12 g/dl from Month -6 to Month -1 will be compared with the proportion of patients with at least 5 measurements and with 80% of these measurements within target range of 10 to 12 g/dl from Month 1 to Month 6 (non-inferiority testing).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2017)
  • Change in the proportion of patients with haemoglobin within the target range as compared to historical control period (superiority testing) [ Time Frame: Month -6 to Month -1 compared with Month +1 to Month +6 ]
    The proportion of patients with at least 5 (standard of care, approximately monthly) Hb measurements and with 80% of these measurements within the Hb target range of 10 to 12 g/dl from Month -6 to Month -1 will be compared with the proportion of patients with at least 5 measurements and with 80% of these measurements within target range of 10 to 12 g/dl from Month 1 to Month 6 (superiority testing).
  • Change in haemoglobin fluctuations as compared to historical control period [ Time Frame: Month -6 to Month -1 compared with Month +1 to Month +6 ]
    The Hb fluctuation in patients with at least 5 (standard of care, approximately monthly) Hb measurements from Month -6 to Month -1 and from Month 1 to Month 6 as measured by Hb, Coefficient of Variation (CV), and Standard Deviation (SD) from Month -6 to Month -1 period versus Month 1 to Month 6.
  • Change in cumulative ESA dose as compared to historical control period [ Time Frame: Month -6 to Month -1 compared with Month +1 to Month +6 ]
    Cumulative ESA dose from Month -6 to Month -1 versus cumulative ESA dose from Month 1 to Month 6.
  • Change in cumulative IV iron dose as compared to historical control period [ Time Frame: Month -6 to Month -1 compared with Month +1 to Month +6 ]
    Cumulative IV iron dose from Month -6 to Month -1 versus cumulative IV iron dose from Month +1 to Month +6.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial
Official Title  ICMJE ANEMEX UK Trial: Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial
Brief 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.
Detailed Description

Fresenius Medical Care has developed an algorithm that uses a data-driven computational intelligence model based on an artificial neural network architecture (ACM) to generate individualised ESA dose recommendations from a history of dose and response information and specific patient demographic characteristics.

The ACM has been validated and complies with the European requirements for medical devices. The ACM was classified as a Class I medical device in accordance with Directive 93/42/EEC. A proof of concept trial was conducted in 3 NephroCare dialysis clinics (managed by Fresenius) in the Czech Republic, Portugal, and Spain. It could be shown that the introduction of ACM-guided therapy led to a significant decrease in median darbepoetin doses and to a significant increase in on-target haemoglobin (Hb) values along with a decrease in Hb fluctuation. Moreover, a retrospective trial conducted in NephroCare clinics in Portugal, suggested that ACM is able to reliably predict the long-term response to ESA and iron therapy in patients undergoing haemodialysis.

The current trial will test the applicability of the ACM outside of Fresenius clinics in a public hospital setting in the UK. Both intravenous (IV) iron and ESA doses will be recommended by the algorithm. The effectiveness of ACM-guided therapy on several anaemia outcomes will be assessed in adult patients with End Stage Renal Disease (ESRD).This trial will be conducted at 1 main unit and 5 satellite units at King's College Hospital, London, UK, in patients with ESRD who are routinely undergoing haemodialysis.

This trial is designed to assess the effectiveness of the 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 will consist of a retrospective control period and a prospective period. During the prospective period, the ACM will be used to facilitate the Investigators' decision making and will help the Investigators to administer a personalised IV iron and 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.

The planned overall duration of the trial is 18 months (12 months recruitment period + 6 months until last patient last visit). The planned duration of prospective treatment for an individual patient will be 6 months. The collection of retrospective data from medical records covering a period of 6 months will take place as soon as the Informed Consent Form (ICF) is signed but at the latest at baseline.

Data will be collected at designated time Points (monthly) throughout the Trial once the ICF is signed: at the latest at baseline (collection of retrospective data), at baseline (start of prospective documentation), and for the observation time points (Month 1 to Month 6). However, examinations will follow routine clinical practice at the site according to the Investigator's decision.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
The trial will consist of a retrospective control period and a prospective period. During the prospective period, the ACM will be used to facilitate the Investigators' decision making and will help the Investigators to administer a personalised IV iron and ESA therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective (historical) period of the trial. Thus, patients can serve as their own control.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Anemia
  • End Stage Renal Disease
Intervention  ICMJE
  • 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
    Other Names:
    • Venofer
    • iron sucrose
  • Drug: Erythropoiesis-Stimulating Agent (ESA)
    ESA given monthly as required over 6 months - dose determined by the ACM and as agreed by the investigator
    Other Name: epoetin beta
Study Arms  ICMJE Experimental: Anemia Control Model IV iron and ESA

Anemia Control Model (ACM) algorithm to recommend monthly IV and ESA dose over a 6 month period

IV iron: given monthly as required - dosing recommendation by ACM over 6 a month period

Erythropoiesis-Stimulating Agent (ESA): given monthly as required - dosing recommendation by ACM over 6 a month period

Interventions:
  • Device: Anemia Control Model (ACM)
  • Drug: IV iron
  • Drug: Erythropoiesis-Stimulating Agent (ESA)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 6, 2020)
88
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2017)
240
Actual Study Completion Date  ICMJE May 21, 2019
Actual Primary Completion Date May 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 19 to 90 years
  • On haemodialysis for the past 18 months prior to baseline
  • Treatment with IV iron sucrose during the past 6 months according to the respective Summary of Product Characteristics (SmPC)
  • Treatment with epoetin beta during the past 6 months according to the respective SmPC
  • Regular Hb measurements and at least 5 (standard of care, approximately monthly) Hb measurements during the past 6 months
  • Ferritin measurements during the past 6 months (at least 2 measurements)
  • Signed informed consent

Exclusion Criteria:

  • Life expectancy <6 months
  • One or more Hb measurements <8 g/dl during the control period
  • Living-donor transplant scheduled within the next 6 months
  • Scheduled for switch to peritoneal dialysis or home haemodialysis
  • Blood transfusion during the past 9 months
  • Pregnancy or breast feeding
  • Active infection
  • Current malignancy or haematological disorder
  • Previous severe hypersensitivity reaction to IV iron sucrose
  • Serious allergic reactions to darbepoetin alfa or epoetin alfa/beta/zeta, respectively
  • Current treatment with PEGylated erythropoietin
  • Surgery in the past 6 months
  • Surgery scheduled within the next 6 months
  • Participation in a clinical trial in the past 7 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03214627
Other Study ID Numbers  ICMJE VEN-DEV-401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vifor Fresenius Medical Care Renal Pharma
Study Sponsor  ICMJE Vifor Fresenius Medical Care Renal Pharma
Collaborators  ICMJE
  • Worldwide Clinical Trials
  • Fresenius Medical Care Deutschland GmbH
Investigators  ICMJE
Principal Investigator: Iain Macdougall King's College Hospital NHS Trust
PRS Account Vifor Fresenius Medical Care Renal Pharma
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP