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

NCT05530291 | Completed

• 1 other identifier: 1517-MA-3435
• Study Type: observational
• Target: 85,259
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease; EuCliD; Erythropoietin hyporesponsiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Phase 1 Part: Correlation of hyporesponsiveness and patient characteristics over time

  Up to 12 months

• Phase 1 Part: Time from the start of ESA dose to the first hyporesponsive event

  Up to 12 months

• Phase 1 Part: Distribution of ESA hyporesponsiveness patients

  Up to 12 months

• Phase 1 Part: Baseline characteristics

  Day 1 (start of ESA treatment)

• Phase 1 Part: Characteristics on date of first incidence satisfying hyporesponsiveness criteria

  Up to 12 months

Study Arms (2)

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.

Other: Non-interventional

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.

Other: Non-interventional

Interventions

Non-interventional OTHER

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

ESA hyporesponsive CKD patients; ESA responsive CKD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be patients with anemia of CKD treated with ESA in stage 5D, i.e., on renal replacement therapy (RRT), including extracorporeal RRT and peritoneal dialysis (PD) prevalent as patients in Fresenius Medical Care (FME)'s Nephrocare centers and documented in the EuCliD data base between January 1st 2015 and December 31st 2021.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (1)

Site DE49001

Bad Homburg, 61352, Germany

Location

Related Publications (1)

• Atzinger C, Arens HJ, Neri L, Arkossy O, Garbelli M, Jiletcovici A, Snijder R, Leyland K, Khalife N, Ali M, Feuersenger A. Hyporesponsiveness to Erythropoiesis-Stimulating Agents in Dialysis-Dependent Patients with Anaemia of Chronic Kidney Disease: A Retrospective Observational Study. Adv Ther. 2025 Jan;42(1):471-489. doi: 10.1007/s12325-024-03015-4. Epub 2024 Nov 25.

  PMID: 39581908 DERIVED

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 7, 2022
• Study Start: November 18, 2022
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)