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

An observational study of Chronic Kidney Disease, run by Astellas Pharma Global Development, Inc. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Non-interventional
How many people: 85,259 participants
Where: 1 siteGermany
Study dates: 18 Nov 2022to 22 Nov 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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)

Show all 14Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Site DE49001
Bad Homburg, 61352

Other trials in Germany

About this study

Read the 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).

Conditions: Chronic Kidney Disease
Being tested: Non-interventional
Keywords: Chronic kidney disease, EuCliD, Erythropoietin hyporesponsiveness
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05530291
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Non-interventional

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 12 months

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202222 Nov 2022

First posted7 Sep 2022
Study start18 Nov 2022
Primary completion22 Nov 2022
Study completion22 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 85,259 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05530291
Sponsor's protocol ID: 1517-MA-3435
Status last verified: Oct 2024
First submitted: 5 Sep 2022
Last updated: 7 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

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.
PubMed 39581908

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incidence and Clinical Burden of Erythropoietin Hyporesponsiveness - a Retrospective Database Analysis
ClinicalTrials.gov ID: NCT05530291
Acronym / sponsor ID: 1517-MA-3435
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease, EuCliD, Erythropoietin hyporesponsiveness
Study type: Observational
Recruitment status: Completed
Enrolment: 85,259 participants (actual)
Lead sponsor: Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
Study start: 18 Nov 2022 (actual)
Primary completion: 22 Nov 2022 (actual)
Study completion: 22 Nov 2022 (actual)
First posted: 7 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
ESA hyporesponsive CKD patients	–	Other: Non-interventionalA 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.
ESA responsive CKD patients	–	Other: Non-interventionalA 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (14 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Non-interventionalEpidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs	Other	ESA hyporesponsive CKD patients, ESA responsive CKD patients

Primary outcome

Phase 1 Part: Rate of ESA hyporesponsive events
Time frame: 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.

7 secondary outcomes

Phase 1 Part: Correlation of hyporesponsiveness and patient characteristics over time
Time frame: Up to 12 months
Phase 1 Part: Time from the start of ESA dose to the first hyporesponsive event
Time frame: Up to 12 months
Phase 1 Part: Distribution of ESA hyporesponsiveness patients
Time frame: Up to 12 months
Phase 1 Part: Baseline characteristics
Time frame: Day 1 (start of ESA treatment)
Phase 1 Part: Characteristics on date of first incidence satisfying hyporesponsiveness criteria
Time frame: Up to 12 months
Phase 1 Part: Percentage of ESA hyporesponsiveness in relation to the KDIGO definition
Time frame: At 12 months
Phase 1 Part: Percentage of ESA hyporesponsiveness per Clinical Practicability Algorithm
Time frame: At 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
Derived from this study: PubMed 39581908Atzinger 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.
Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

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End Stage Renal Disease
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Astellas Pharma Global Development, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease, run by Astellas Pharma Global Development, Inc. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 Part: Rate of ESA hyporesponsive events (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05530291, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.