Kidney Week

Abstract: TH-PO252

The Impact of Newly Developed Inflammation, Characterized by Rise in C-Reactive Protein, on Anemia Management Practices in Hemodialysis Patients: A Before-After Design in the DOPPS

Session Information

• Anemia and Iron Metabolism: Clinical
  October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Anemia and Iron Metabolism

• 202 Anemia and Iron Metabolism: Clinical

Authors

• Karaboyas, Angelo, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States

Angelo Karaboyas,

• Morgenstern, Hal, University of Michigan, Ann Arbor, Michigan, United States

Hal Morgenstern,

• Vanholder, Raymond C., University Hospital Gent, Gent, Belgium

Raymond C. Vanholder,

• Fleischer, Nancy L., University of Michigan, Ann Arbor, Michigan, United States

Nancy L. Fleischer,

• Schaubel, Douglas E., University of Michigan, Ann Arbor, Michigan, United States

Douglas E. Schaubel,

• Schaeffner, Elke, Charite , Berlin, Germany

Elke Schaeffner,

• Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan

Tadao Akizawa,

• Dhalwani, Nafeesa N., Evidera, London, United Kingdom

Nafeesa N. Dhalwani,

• Sinsakul, Marvin, AstraZeneca, Gaithersburg, Maryland, United States

Marvin Sinsakul,

• Pisoni, Ronald L., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States

Ronald L. Pisoni,

• Robinson, Bruce M., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States

Bruce M. Robinson,

Background

Inflammation, as assessed by a rising C-reactive protein (CRP), may lower hemoglobin (Hgb) level and lead to increased ESA dose to support the unmet need.

Methods

Using data from Dialysis Outcomes and Practice Patterns Study (DOPPS) phases 4-6 (2009-2018) in 10 countries where CRP is routinely measured, we identified hemodialysis patients who had a new inflammation event, defined here as CRP >10 mg/L following a 3-month period with all available CRP measurements ≤5 mg/L. In a “before-after” design treating patients as their own controls, we used adjusted linear mixed models to estimate within-patient effects of inflammation on changes in Hgb and log-transformed ESA dose, comparing mean values from the 3 months “before” vs. “after” observing high CRP. Sensitivity analyses used different CRP thresholds as a proxy for a new inflammation event (e.g., ≤3 to >10 mg/L, ≤5 to >20 mg/L).

Results

Among 12389 patients, 40158 CRP values (21% of all measurements) were >10 mg/L, and 3752 measurements (from 2976 patients) met the eligibility criteria (Fig). In the “before” vs. “after” periods, mean Hgb was 11.2 vs. 10.9 g/dL and mean ESA dose was 6347 vs. 6994 units/week. In 56% of the cases, patients experienced either a Hgb drop of >0.5 g/dL (40% of cases) or a >20% increase in ESA dose (33% of cases). In adjusted models, the average within-patient change was 0.26 g/dL (95% CI: 0.22, 0.30) lower Hgb and an 8.6% (95% CI: 6.4, 10.8) increase in ESA dose. Results were robust to sensitivity analyses varying the CRP thresholds.

Conclusion

After patients experienced an inflammation event, Hgb levels declined and ESA doses rose, suggestive of increased ESA resistance. Routine measurement of CRP is not practiced in the US but could help identify inflamed patients. These patients may benefit from proactive adjustment of medications or, in the future, anemia therapies that may be less subject to effects of inflammation.

Funding

• NIDDK Support – This analysis was supported by AstraZeneca. The DOPPS Program is supported by Amgen, Kyowa Hakko Kirin, Baxter Healthcare. Additional support for specific projects and countries is provided by AstraZeneca, European Renal Association-European Dialysis & Transplant Association (ERA-EDTA), Fresenius Medical Care Asia-Pacific Ltd, Fresenius Medical Care Canada Ltd, German Society of Nephrology (DGfN), Janssen, Japanese Society for Peritoneal Dialysis (JSPD), Keryx, Kidney Care UK, MEDICE Arzneimittel Pütter GmbH & Co KG, Proteon, and Vifor Fresenius Medical Care Renal Pharma. Public funding and support is provided for specific DOPPS projects, ancillary studies, or affiliated research projects by National Health & Medical Research Council (NHMRC) in Australia, Cancer Care Ontario (CCO) through the Ontario Renal Network (ORN) in Canada, French National Institute of Health and Medical Research (INSERM) in France, Thailand Research Foundation (TRF), Chulalongkorn University Matching Fund, King Chulalongkorn Memorial Hospital Matching Fund, and the National Research Council of Thailand (NRCT) in Thailand, National Institute for Health Research (NIHR) via the Comprehensive Clinical Research Network (CCRN) in the United Kingdom, and National Institutes of Health (NIH) in the US. All support is provided without restrictions on publications. All grants are made to Arbor Research Collaborative for Health and not to Mr. Karaboyas directly.