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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530291
• Other study ID #: 1517-MA-3435
• Status: Completed
• Start date: November 18, 2022
• Est. completion date: November 22, 2022

Study information

• Verified date: April 2024
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85259
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Non-interventional
Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs

Locations

Country	Name	City	State
Germany	Site DE49001	Bad Homburg

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Phase 1 Part: Distribution of ESA hyporesponsiveness patients	Hyporesponsive events will be categorized into isolated, intermittent and chronic, and distribution will be evaluated.	Up to 12 months
Secondary	Phase 1 Part: Baseline characteristics	Demographics and clinical characteristics of patients who developed ESA hyporesponse and those that did not (responders) will be compared.	Day 1 (start of ESA treatment)
Secondary	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.	Up to 12 months
Secondary	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.	At 12 months
Secondary	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.	At 12 months

External Links

•   Link to results and other applicable study documents on the Astellas Clinical Trials website