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Abstract: SA-PO819

Predictive Hierarchical Modeling of Determinants of Outcomes of Anemia Management with Binocrit®, a Biosimilar Epoetin Alfa, in the Hemodialysis Setting (MONITOR-CKD5 Study)

Session Information

Category: Dialysis

  • 605 Dialysis: Anemia and Iron Metabolism


  • Dellanna, Frank, MVZ DaVita Rhein-Ruhr GmbH, Duesseldorf, Germany
  • Goldsmith, David, Guy's & St. Thomas' NHS Foundation Trust, Great Maze Pond, London, United Kingdom
  • Mann, Johannes F., KfH Nierenzentrum, München, Germany
  • Zaoui, Philippe, Clinic of Nephrology Chu Grenoble, Grenoble, France
  • Combe, Christian, CHU de Bordeaux, Bordeaux, France
  • Krendyukov, Andriy, Sandoz Biopharmaceuticals, Holzkirchen, Germany
  • Abraham, Ivo, University of Arizona, Tucson, Arizona, United States
  • Macdonald, Karen, Matrix 45, Tucson, Arizona, United States

The European observational MONITOR-CKD5 study demonstrated the real-world effectiveness of Binocrit® in renal anaemia. Patients treated for up to 24 months showed stable dosing patterns and stable hemoglobin (Hb) outcomes. Predictive hierarchical modeling was applied to identify determinants of outcomes of interest.


A subset of 484 patients with complete 24-month data was used to investigate pre-specified potential determinants of the following outcomes: (1) mean Hb of last 4 visits, estimated using Wald test (hierarchical linear regression); risk for (2) chronic hyporesponsiveness, (3) overnight hospitalization, (4) thromboembolic events (TEE), (5) mortality. Risks were estimated using adjusted odds ratios (OR; hierarchical logistic regression). The intraclass correlation coefficient (ICC) quantified the proportion of variance in outcome attributable to a center class effect.


The following determinants were retained for each outcome of interest at p<0.05. For mean Hb of last 4 visits (ICC=0.0477): age (+0.0067g/dL per 1 year over mean); chronic infection or inflammatory disease at baseline (-0.3395g/dL if present); Kt/V≥1.2 at baseline (+0.3181g/dL if present). For risk of chronic hyporesponsiveness (ICC=0.1599): chronic infection or inflammatory disease at baseline (OR=3.055). For risk of hospitalization (ICC=0.2349): no determinants retained despite ICC. For TEE risk (ICC=0.0550): serum albumin ≥3g/dL (OR=0.396); Kt/V≥1.2 at baseline (OR=0.455); age (per 1 year of age over mean, OR=1.021). For overall mortality (ICC=0.1156): deficient iron status (OR=2.354); Kt/V≥1.2 at baseline (OR=0.316); age (per 1 year over mean, OR=1.064).


In hemodialysis patients receiving Binocrit® for 2 years, determinants of positive Hb outcome included Kt/V≥1.2 and serum albumin ≥3g/dL. The presence of chronic infection or inflammatory disease and deficient iron status were predictive of poorer Hb outcomes. Age was associated positively with Hb levels, but negatively with TEE and mortality risk. Consistent with findings from the DOPPS and ESAM observational studies, all determinants except for age are clinically modifiable or manageable.


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