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.
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).
Study Type
OBSERVATIONAL
Enrollment
85,259
Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs
Site DE49001
Bad Homburg, Germany
Phase 1 Part: Rate of ESA hyporesponsive events
The total number of patients with a new hyporesponsive event in relation to National Institute for Health and Care Excellence, UK (NICE) guidelines within a year after the ESA dose start will be counted as incidence. For deriving the incidence rate, the number of incidence cases will be divided by the sum of the time (days) each patient was observed within this group, totaled for all patients in this ESA subgroup.
Time frame: Up to 12 months
Phase 1 Part: Correlation of hyporesponsiveness and patient characteristics over time
Visual representation of hyporesponsiveness and patient characteristics (Hemoglobin \[Hb\] values, ESA dose, anemia treatment, and NICE defined Hyporesponsiveness) to assess relationship to one another.
Time frame: Up to 12 months
Phase 1 Part: Time from the start of ESA dose to the first hyporesponsive event
The time until the first hyporesponsiveness event will be estimated.
Time frame: Up to 12 months
Phase 1 Part: Distribution of ESA hyporesponsiveness patients
Hyporesponsive events will be categorized into isolated, intermittent and chronic, and distribution will be evaluated.
Time frame: Up to 12 months
Phase 1 Part: Baseline characteristics
Demographics and clinical characteristics of patients who developed ESA hyporesponse and those that did not (responders) will be compared.
Time frame: Day 1 (start of ESA treatment)
Phase 1 Part: Characteristics on date of first incidence satisfying hyporesponsiveness criteria
Demographics and clinical characteristics of patients who developed ESA hyporesponse will be compared with a matched control group.
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Time frame: Up to 12 months
Phase 1 Part: Percentage of ESA hyporesponsiveness in relation to the KDIGO definition
Percentages in relation to the Kidney Disease: Improving Global Outcomes (KDIGO) definition will be provided for the ESA hypo-responders and the ESA responders.
Time frame: At 12 months
Phase 1 Part: Percentage of ESA hyporesponsiveness per Clinical Practicability Algorithm
Percentages per Clinical Practicability Algorithm will be provided for the ESA hyporesponders and the ESA responders.
Time frame: At 12 months