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Original ArticlesMaintenance Dialysis
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Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD

Michel Fischbach, Elke Wühl, Sylvie C. Meyer Reigner, Zoe Morgan and Franz Schaefer
CJASN January 2018, 13 (1) 81-90; DOI: https://doi.org/10.2215/CJN.03570417
Michel Fischbach
Nephrology Dialysis Transplantation Children's Unit, Centre Hospitalier Universitaire Hautepierre, Strasbourg, France;
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Elke Wühl
Pediatric Nephrology, Heidelberg University Hospital, Heidelberg, Germany;
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Sylvie C. Meyer Reigner
Clinical Science F. Hoffmann-La Roche Ltd., Basel, Switzerland and
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Zoe Morgan
Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
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Franz Schaefer
Pediatric Nephrology, Heidelberg University Hospital, Heidelberg, Germany;
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    Figure 1.

    Patient disposition. ESA, erythropoiesis-stimulating agent.

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    Figure 2.

    Hemoglobin (Hb) was maintained within the target range in the higher conversion factor group during the core trial period. Mean Hb values with 95% confidence intervals are shown. Dashed lines indicate target range.

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    Figure 3.

    Changes in hemoglobin (Hb) were comparable in subgroups by age or previous ESA use in the higher conversion factor group. Mean changes with 95% confidence intervals are shown. Dashed lines indicate target range.

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    Figure 4.

    Reticulocytes showed expected cyclical variation with no overall increase. Mean absolute counts with 95% confidence intervals are shown.

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    Figure 5.

    Hemoglobin (Hb) concentrations were maintained in both groups in patients who entered the extension phase. Mean Hb values with 95% confidence intervals are shown. Dashed lines indicate the target range.

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    Table 1.

    Baseline demographic and disease characteristics

    CharacteristicGroup 1, Intermediate Conversion Factor, n=16Group 2, Higher Conversion Factor, n=48Total, n=64
    Conversion factor used4 µg every 4 wk for each weekly dose of 250 IU epoetin or 1.1 µg darbepoetin4 µg every 4 wk for each weekly dose of 125 IU epoetin or 0.55 µg darbepoetin
    Boys, n (%)11 (69)23 (48)34 (53)
    Mean age, yr (range)11.3 (7–16)13.0 (6–17)12.6 (6–17)
     Age 6–11 yr, n (%)9 (56)16 (33)25 (39)
     Age 12–17 yr, n (%)7 (44)32 (67)39 (61)
    Mean hemoglobin, g/dl11.3±0.511.3±0.511.1±0.5
    Mean weight, kg33±1239±1438±14
    Mean height, cm139±18144±17143±17
    Mean Z score for height−1.55±1.84−1.78±1.41−1.72±1.51
    Mean Kt/V urea1.57±0.381.60±0.411.60±0.40
    Vascular access arteriovenous fistula, n (%)13 (81)31 (65)44 (69)
    Race, n (%)
     White11 (69)35 (73)46 (72)
     Black1 (6)1 (2)2 (3)
     Asian2 (13)5 (10)7 (11)
     Other2 (13)7 (15)9 (14)
    Etiology of CKD, n (%)
     Hereditary nephropathy3 (19)13 (27)16 (25)
     Hypoplastic/dysplastic kidneys2 (13)12 (25)14 (22)
     Obstructive uropathy4 (25)8 (17)12 (19)
     Other GN2 (13)7 (15)9 (14)
     Systemic disease1 (6)6 (13)7 (11)
     Reflux nephropathy0 (0)5 (10)5 (8)
     FSGS3 (19)1 (2)4 (6)
    Median years from first dialysis1.5 (1.1–3.4)1.2 (0.5–4.1)1.3 (0.5–3.7)
    Median years from first ESA1.8 (1.2–3.7)1.2 (0.5–3.1)1.3 (0.5–3.1)
    Median previous ESA dose
     Darbepoetin alfa, µg/wk17.5 (9–25)20.0 (10–20)20.0 (10–20)
     Epoetin alfa/beta, IU/wk4500 (2250–7500)6000 (4000–6000)6000 (3000–6000)
    • Mean values are shown ±1 SD; median values are shown with interquartile range. ESA, erythropoiesis-stimulating agent.

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    Table 2.

    Ratio of the dose during the evaluation period to the first dose

    Dose Ratio, Median (Interquartile Range)nGroup 1 (Intermediate Conversion Factor)nGroup 2 (Higher Conversion Factor)
    All patients121.59 (1.19–2.47)361.00 (0.66–1.52)
    Age group
     Patients aged 6–11 yr61.81 (0.76–2.50)111.25 (1.00–1.60)
     Patients aged 12–17 yr61.59 (1.25–2.44)250.98 (0.62–1.48)
    Previous ESA treatment
     Darbepoetin alfa61.82 (1.17–2.44)191.00 (0.75–1.57)
     Epoetin alfa/beta61.59 (1.25–2.50)171.00 (0.60–1.25)
    • ESA, erythropoiesis-stimulating agent.

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    Table 3.

    Results of safety monitoring

    EventGroup 1 (Intermediate Conversion Factor)Group 2 (Higher Conversion Factor)Total
    Core study periodn=16n=48n=64
     Adverse event, n (%)12 (75)37 (77)49 (77)
     Serious adverse event, n (%)4 (25)12 (25)16 (25)
     Fatal adverse event, n (%)01 (2)1 (2)
     Withdrawal due to adverse event, n (%)01 (2)1 (2)
     Blood transfusions, n (%)1 (11)2 (4)3
     Incidence of individual adverse events, n (%)a
      Headache1 (6)8 (17)9 (14)
      Nasopharyngitis0 (0)9 (19)9 (14)
      Hypertension1 (6)7 (15)8 (13)
      Vomiting2 (13)4 (8)6 (9)
      Abdominal pain1 (6)3 (6)4 (6)
      Bronchitis1 (6)3 (6)4 (6)
    Extension periodn=9n=28n=37
     Adverse event, n (%)4 (44)23 (82)27 (73)
     Serious adverse event, n (%)1 (11)8 (28)9 (24)
     Fatal adverse event, n (%)0 (0)0 (0)0 (0)
     Withdrawal due to adverse event, n (%)0 (0)0 (0)0 (0)
     Incidence of individual adverse events, n (%)a
      Nasopharyngitis0 (0)7 (25)7 (19)
      Headache0 (0)6 (21)6 (16)
      Hypertension0 (0)5 (18)5 (14)
      Bronchitis1 (11.1)2 (7)3 (8)
      Pharyngitis0 (0)3 (11)3 (8)
    • ↵a Adverse events with an overall incidence ≥6%.

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Clinical Journal of the American Society of Nephrology: 13 (1)
Clinical Journal of the American Society of Nephrology
Vol. 13, Issue 1
January 06, 2018
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Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD
Michel Fischbach, Elke Wühl, Sylvie C. Meyer Reigner, Zoe Morgan, Franz Schaefer
CJASN Jan 2018, 13 (1) 81-90; DOI: 10.2215/CJN.03570417

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Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD
Michel Fischbach, Elke Wühl, Sylvie C. Meyer Reigner, Zoe Morgan, Franz Schaefer
CJASN Jan 2018, 13 (1) 81-90; DOI: 10.2215/CJN.03570417
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Keywords

  • chronic kidney disease
  • anemia
  • epoetin
  • C.E.R.A.
  • adult
  • Humans
  • continuous erythropoietin receptor activator
  • epoetin beta
  • Hematinics
  • Epoetin Alfa
  • kidney transplantation
  • erythropoietin
  • Polyethylene Glycols
  • Hemoglobins
  • Renal Insufficiency, Chronic
  • renal dialysis

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