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

NCT03214627 | Terminated DMC

• 1 other identifier: VEN-DEV-401
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Change in the proportion of patients with haemoglobin within the target range as compared to the historical control period (non-inferiority testing)

  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).

  Month -6 to Month -1 compared with Month +1 to Month +6

Secondary Outcomes (4)

• Change in the proportion of patients with haemoglobin within the target range as compared to historical control period (superiority testing)

  Month -6 to Month -1 compared with Month +1 to Month +6

• Change in haemoglobin fluctuations as compared to historical control period

  Month -6 to Month -1 compared with Month +1 to Month +6

• Change in cumulative ESA dose as compared to historical control period

  Month -6 to Month -1 compared with Month +1 to Month +6

• Change in cumulative IV iron dose as compared to historical control period

  Month -6 to Month -1 compared with Month +1 to Month +6

Study Arms (1)

Anemia Control Model IV iron and ESA

EXPERIMENTAL

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

Device: Anemia Control Model (ACM); Drug: IV iron; Drug: Erythropoiesis-Stimulating Agent (ESA)

Interventions

Anemia Control Model (ACM) DEVICE

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.

Anemia Control Model IV iron and ESA

IV iron DRUG

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

Also known as: Venofer, iron sucrose

Anemia Control Model IV iron and ESA

Erythropoiesis-Stimulating Agent (ESA) DRUG

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

Also known as: epoetin beta

Anemia Control Model IV iron and ESA

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vifor Fresenius Medical Care Renal Pharma: lead
• Worldwide Clinical Trials: collaborator
• Fresenius Medical Care Deutschland GmbH: collaborator

Study Sites (1)

Kings College Hospital

London, United Kingdom

Location

Related Publications (3)

• Barbieri C, Mari F, Stopper A, Gatti E, Escandell-Montero P, Martinez-Martinez JM, Martin-Guerrero JD. A new machine learning approach for predicting the response to anemia treatment in a large cohort of End Stage Renal Disease patients undergoing dialysis. Comput Biol Med. 2015 Jun;61:56-61. doi: 10.1016/j.compbiomed.2015.03.019. Epub 2015 Mar 23.

  PMID: 25864164 BACKGROUND

• Barbieri C, Molina M, Ponce P, Tothova M, Cattinelli I, Ion Titapiccolo J, Mari F, Amato C, Leipold F, Wehmeyer W, Stuard S, Stopper A, Canaud B. An international observational study suggests that artificial intelligence for clinical decision support optimizes anemia management in hemodialysis patients. Kidney Int. 2016 Aug;90(2):422-429. doi: 10.1016/j.kint.2016.03.036. Epub 2016 Jun 2.

  PMID: 27262365 BACKGROUND

• Barbieri C, Bolzoni E, Mari F, Cattinelli I, Bellocchio F, Martin JD, Amato C, Stopper A, Gatti E, Macdougall IC, Stuard S, Canaud B. Performance of a Predictive Model for Long-Term Hemoglobin Response to Darbepoetin and Iron Administration in a Large Cohort of Hemodialysis Patients. PLoS One. 2016 Mar 3;11(3):e0148938. doi: 10.1371/journal.pone.0148938. eCollection 2016.

  PMID: 26939055 BACKGROUND

MeSH Terms

Conditions

Anemia; Kidney Failure, Chronic

Interventions

ferryl iron; Ferric Oxide, Saccharated; Hematinics; epoetin beta

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Iain Macdougall

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 11, 2017
• Study Start: December 10, 2018
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

GB (1)