Incidence and Clinical Burden of Erythropoietin Hyporesponsiveness - a Retrospective Database Analysis

Astellas

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Other: Non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT05530291

1517-MA-3435

Details and patient eligibility

About

This study consists of two phases. The purpose of phase 1 is to identify incidence and patterns of erythropoiesis-stimulating agent (ESA) hyporesponsiveness and its associated factors in ESA treated patients. The purpose of phase 2 to identify outcomes associated with ESA hyporesponsiveness. Key aspects of the phase 2 study design will entirely depend on the results from phase 1.

Full description

This is a retrospective database analysis of patients with anemia associated with chronic kidney disease (CKD) treated with ESAs from January 1st 2015 - December 31st 2021. Data will be derived from European Clinical Database (EuCliD).

Enrollment: 85,259 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients

• Patient has a diagnosis of chronic kidney disease valid between January 1st, 2015, and December 31st, 2021 and is documented in the EuCliD database (incident and prevalent patients)
• Patient who is treated with renal replacement therapy (RRT) (CKD Stage 5) during the study period
• Patient receiving erythropoiesis-stimulating agent (ESA) therapy, within the data collection period having EuCliD data available for a period of the previous 30 days before Index Date but not strictly limited to patients that enter the study period as ESA naïve patients
• Patient having provided consent for secondary use of their data for research purposes
• Patient has a known ESA administration route (intravenous/subcutaneous)
• Patient with a hemoglobin value available at baseline (+/- 20 days allowed) and at least one valid hemoglobin value afterwards
• Patient having at least one body weight value available

Hyporesponsive Cohort

• Patients meeting the hyporesponsive criteria on at least one occasion. The criteria for ESA hyporesponsive will follow the National Institute for Health and Care Excellence, UK (NICE) guidelines:

  • for epoetin alfa, 300 IU/kg/week or more of subcutaneous epoetin or 450 IU/kg/week or more of intravenous epoetin
  • for darbepoetin, dose ≥ 1.5 μg/kg per week

Responsive Cohort

• Patients with all ESA doses lower than those defined by the hyporesponsive criteria

Exclusion criteria

• Patient with evidence of hereditary hemolytic anemia (International Classification of Diseases 10th Revision [ICD-10] code D58.9)
• Patient receiving transplant within 6 months prior to Index Date

Trial design

85,259 participants in 2 patient groups

ESA hyporesponsive CKD patients

Description:

A cohort of patients who meets ESA hyporesponsiveness criteria as well as other common criteria will be created from the Fresenius Medical Care´s proprietary clinical database called EuCliD.

Treatment:

Other: Non-interventional

ESA responsive CKD patients

Description:

A cohort of patients who meets ESA responsiveness criteria as well as other common criteria will be created from the Fresenius Medical Care´s proprietary clinical database called EuCliD.

Treatment:

Other: Non-interventional