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Original ArticlesChronic Kidney Disease
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Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD

A Randomized Noninferiority Trial

Francesco Locatelli, Thierry Hannedouche, Steven Fishbane, Zoe Morgan, Delphine Oguey and William B. White
CJASN December 2019, 14 (12) 1701-1710; DOI: https://doi.org/10.2215/CJN.01380219
Francesco Locatelli
1Retired from Alessandro Manzoni Hospital, ASST Lecco, Lecco, Italy;
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Thierry Hannedouche
2School of Medicine, University of Strasbourg, Strasbourg, France;
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Steven Fishbane
3Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York;
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Zoe Morgan
4Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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Delphine Oguey
5Clinical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
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William B. White
6Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, Connecticut
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    Figure 1.

    Patient disposition. The most common reason for discontinuation in patients in the ‘other’ category was the patient moving away from participating dialysis units. *Kidney transplant was a prespecified reason for withdrawal from the trial.

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    Figure 2.

    Hematologic and iron parameters during the study. (A) Hemoglobin, (B) ferritin, and (C) transferrin saturation. Values shown are median with IQRs.

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    Figure 3.

    Time-to-event curves. (A) Death from any cause, nonfatal stroke, or nonfatal myocardial infarction (primary end point) and (B) death from any cause.

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    Figure 4.

    Subgroup analysis of the primary end point by baseline patient and disease factors.

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    Table 1.

    Baseline characteristics of the patients

    Characteristic, n (%)Reference ESA (n=1409)Methoxy Polyethylene Glycol-Epoetin Beta (n=1409)
    Median age, yr (interquartile range)65 (53–74)64 (53–74)
    Men828 (59)805 (57)
    Region
     Europe1038 (74)1039 (74)
     Asia162 (11)150 (11)
     Australia73 (5)75 (5)
     Latin America136 (10)145 (10)
    Treatment condition
     Correction273 (19)273 (19)
     Maintenance1136 (81)1136 (81)
    On dialysis1173 (83)1194 (85)
     Years receiving dialysisn=1173n=1194
      <1290 (25)288 (24)
      1–3432 (37)429 (36)
      >3451 (38)477 (40)
     Dialysis modalityn=1173n=1194
      Peritoneal dialysis81 (7)91 (8)
      Hemodialysis1092 (93)1103 (92)
    Cardiovascular risk factors and history
     Ischemic heart disease420 (30)376 (27)
     Peripheral vascular disease234 (17)200 (14)
     Cerebral vascular disease137 (10)131 (9)
     Congestive heart failure202 (14)192 (14)
      NYHA class I54 (4)47 (3)
      NYHA class II121 (9)112 (8)
      NYHA class III30 (2)41 (3)
      NYHA class IV10 (1)15 (1)
      Unknown5 (0)0 (0)
     Venous thrombosis165 (12)164 (12)
     Hypertension1267 (90)1268 (90)
     Hyperlipidemia776 (55)759 (54)
     Diabetes495 (35)496 (35)
     C-reactive protein ≤30 mg/L1288/1386 (93)1283/1379 (93)
    • There were no significant differences between the two arms with regard to any baseline characteristics. ESA, erythropoiesis-stimulating agent; NYHA, New York Heart Association.

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    Table 2.

    Major safety end points

    End PointReference ESA (n=1409)Methoxy Polyethylene Glycol-Epoetin Beta (n=1409)Hazard Ratio (95% CI)P Value
    No. of Patients (%)No. of Patients (%)For NoninferiorityaFor Differenceb
    Primary end point (composite of all-cause death, nonfatal MI, and nonfatal stroke)644 (46)640 (45)1.03 (0.93 to 1.15)0.0040.54
    Secondary end point
     Death557 (40)558 (40)1.06 (0.94 to 1.19)0.36
     Nonfatal MI or stroke191 (14)168 (12)0.91 (0.74 to 1.12)0.39
     Fatal or nonfatal MI158 (11)143 (10)0.95 (0.76 to 1.19)0.66
     Fatal or nonfatal stroke98 (7)89 (6)0.94 (0.70 to 1.25)0.66
    • ESA, erythropoiesis-stimulating agent; 95% CI, 95% confidence interval; MI, myocardial infarction.

    • ↵a P value for the test for noninferiority at a hazard ratio of 1.20 (primary endpoint only).

    • ↵b P value from the Wald test for hazard ratio difference from 1.

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Clinical Journal of the American Society of Nephrology: 14 (12)
Clinical Journal of the American Society of Nephrology
Vol. 14, Issue 12
December 06, 2019
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Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD
Francesco Locatelli, Thierry Hannedouche, Steven Fishbane, Zoe Morgan, Delphine Oguey, William B. White
CJASN Dec 2019, 14 (12) 1701-1710; DOI: 10.2215/CJN.01380219

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Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD
Francesco Locatelli, Thierry Hannedouche, Steven Fishbane, Zoe Morgan, Delphine Oguey, William B. White
CJASN Dec 2019, 14 (12) 1701-1710; DOI: 10.2215/CJN.01380219
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Keywords

  • anemia
  • chronic kidney disease
  • epoetin
  • clinical trial
  • cardiovascular
  • mortality risk
  • Darbepoetin alfa
  • Hematinics
  • C-Reactive Protein
  • cardiovascular diseases
  • intention to treat analysis
  • Random Allocation
  • renal dialysis
  • risk factors
  • continuous erythropoietin receptor activator
  • erythropoietin
  • Myocardial Infarction
  • chronic renal insufficiency
  • Stroke
  • Polyethylene Glycols

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