Incidence and Clinical Burden of Erythropoietin Hyporesponsiveness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85259 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-18

Study Completion Date

2022-11-22

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ESA hyporesponsive CKD patients

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.

Non-interventional

Intervention Type OTHER

Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs

ESA responsive CKD patients

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.

Non-interventional

Intervention Type OTHER

Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs

Interventions

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Non-interventional

Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No