Real-Life Anemia Management Among Patients with Non-Dialysis-Dependent Chronic Kidney Disease in Three European Countries

Abstract

Background

Anemia is prevalent among patients with chronic kidney disease (CKD), yet current evidence indicates that treatment may not adhere to Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. We aimed to document the management of patients with non-dialysis-dependent (NDD)-CKD receiving erythropoiesis-stimulating agent (ESA) therapy in Europe.

Methods

This retrospective, observational study extracted information from medical records in Germany, Spain, and the UK. Eligible patients were adults with NDD-CKD stages 3b–5 who initiated ESA therapy for anemia between January and December 2015. Anemia was defined as hemoglobin (Hb) <13.0 g/dL (males) or <12.0 g/dL (females). Data regarding ESA treatment, treatment response, concomitant iron therapy and blood transfusions were extracted up to 24 months post-ESA initiation, and data on CKD progression until abstraction date.

Results

Eight hundred and forty-eight medical records were abstracted. Approximately 40% received no iron therapy prior to ESA initiation. At ESA initiation, mean ± standard deviation Hb level was 9.8 ± 1.0 g/dL. Most patients received darbepoetin alfa, and switching between ESAs was rare (8.5% of patients). Concomitant intravenous and oral iron therapy was prescribed for 36% and 42% of patients, respectively, during initial ESA therapy. Mean Hb levels reached the target level (10–12 g/dL) within 3–6 months of ESA initiation. Hb, transferrin saturation, and ferritin levels were infrequently monitored from 3 months post-ESA initiation. Rates of blood transfusion, dialysis, and diagnosis of end-stage renal disease were 16.4%, 19.3%, and 24.6%, respectively. Rates of kidney transplant and death were 4.8% and 8.8%, respectively.

Conclusion

Among ESA-treated patients, ESA initiation was in accordance with KDIGO guidelines, but subsequent monitoring of Hb and iron deficiency were suboptimal.

Graphical Abstract

Keywords:

• anemia
• chronic kidney disease
• clinical care process
• erythropoiesis-stimulating agents
• iron therapy
• real-life management

Abbreviations

CKD, chronic kidney disease; CRP, C-reactive protein; eGFR, estimated glomerular filtration rate; ESA, erythropoiesis-stimulating agent; ESRD, end-stage renal disease; Hb, hemoglobin; HCP, healthcare professional; IRB, institutional review board; IV, intravenous; KDIGO, Kidney Disease: Improving Global Outcomes; MPG-EPO, methoxy polyethylene glycol-epoetin beta; NDD, non-dialysis-dependent; TSAT, transferrin saturation.

Data Sharing Statement

Researchers may request access to anonymized participant-level data, trial-level data, and protocols from Astellas-sponsored clinical trials at www.clinicalstudydatarequest.com. For the Astellas criteria on data sharing, see: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx.

Ethics Approval

RTI International’s IRB (Research Triangle Park, North Carolina) determined that this study met all criteria for exemption from ethical considerations (IRB ID: STUDY00020563). In Germany and Spain, the study protocol and its amendments were approved by the Ärztekammer des Saarlandes (ID: 132/19) and the Hospital Universitario Puerta de Hierro Majadahonda (ID: AST-ESA-2019-01), respectively. Under UK Health Research Authority guidelines,¹² this study was not considered to be research and was thus exempt from National Health Service Research Ethics Committee review.

Informed Consent

Due to the nature of this retrospective observational study, patients were not informed that the study is taking place, and consent was not collected. The IRB and ethics committee review packages submitted for this study therefore requested a waiver of informed consent requirements.

Acknowledgments

These data were presented in part as a mini-oral presentation at the 58th ERA-EDTA Congress, June 5–8, 2021; as a poster presentation at the 51st Congress of the Sociedad Española de Nefrología, October 15–18, 2021; as a poster presentation at the 13th annual meeting of the Deutsche Gesellschaft für Nephrologie, September 23–26, 2021; and as a poster presentation at Virtual ISPOR Europe, November 30–December 3, 2021.

Author Contributions

All authors met the following authorship criteria:

• Significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas.

• Drafted or written, or substantially revised or critically reviewed the article.

• Have agreed on the journal to which the article will be submitted.

• Reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage.

• Agree to take responsibility and be accountable for the contents of the article.

Disclosure

DF has received speaker and consultant fees for Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Norgine, and Vifor Pharma. MML is an employee of Astellas Pharma, Inc. KH is an employee of RTI Health Solutions, which provides consulting and other research services to pharmaceutical, device, governmental, and non-governmental organizations. KH works with many companies and does not receive payment or honoraria directly from these companies for services rendered. CA was an employee of RTI Health Solutions at the time of this study and its analysis. RTI Health Solutions received funding from Astellas Pharma Inc. for the design and conduct of this study, statistical analysis, and study report preparation. She is currently affiliated with OPEN Health Evidence and Access, Manchester, UK. MB is an employee of Astellas Pharma Europe, Ltd. EGAS is an employee of Astellas Pharma España S.A. JP has received speaker fees for Astellas, Amgen, AstraZeneca, GSK, Vifor Pharma, and advisory fees from Astellas and Vifor Pharma. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was initiated and supported by Astellas Pharma, Inc. Medical writing support was provided by Iona Easthope, DPhil, of Lumanity, funded by Astellas Pharma Inc.