Chronic Kidney Disease
Conditions
Keywords
Chronic kidney disease, EuCliD, Erythropoietin hyporesponsiveness
Brief summary
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.
Detailed 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).
Interventions
OTHERNon-interventional
Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs
Sponsors
Astellas Pharma Global Development, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Part: Rate of ESA hyporesponsive events | Up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Part: Time from the start of ESA dose to the first hyporesponsive event | Up to 12 months | The time until the first hyporesponsiveness event will be estimated. |
| Phase 1 Part: Distribution of ESA hyporesponsiveness patients | Up to 12 months | Hyporesponsive events will be categorized into isolated, intermittent and chronic, and distribution will be evaluated. |
| Phase 1 Part: Baseline characteristics | Day 1 (start of ESA treatment) | Demographics and clinical characteristics of patients who developed ESA hyporesponse and those that did not (responders) will be compared. |
| Phase 1 Part: Correlation of hyporesponsiveness and patient characteristics over time | Up to 12 months | Visual representation of hyporesponsiveness and patient characteristics (Hemoglobin \[Hb\] values, ESA dose, anemia treatment, and NICE defined Hyporesponsiveness) to assess relationship to one another. |
| Phase 1 Part: Percentage of ESA hyporesponsiveness in relation to the KDIGO definition | At 12 months | Percentages in relation to the Kidney Disease: Improving Global Outcomes (KDIGO) definition will be provided for the ESA hypo-responders and the ESA responders. |
| Phase 1 Part: Percentage of ESA hyporesponsiveness per Clinical Practicability Algorithm | At 12 months | Percentages per Clinical Practicability Algorithm will be provided for the ESA hyporesponders and the ESA responders. |
| Phase 1 Part: Characteristics on date of first incidence satisfying hyporesponsiveness criteria | Up to 12 months | Demographics and clinical characteristics of patients who developed ESA hyporesponse will be compared with a matched control group. |
Countries
Germany
Outcome results
None listed