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

• Status: Terminated
• Trial end date: 2019-05-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vifor Fresenius Medical Care Renal Pharma
• Collaborators: Fresenius Medical Care Deutschland GmbH; Worldwide Clinical Trials
• Treatments: Ferric Oxide, Saccharated; Hematinics; Iron

Criteria

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