Table 3.

Definitions of hyporesponsiveness to ESAs

Definitions of ESA hyporesponsivenessOrganization or study
Failure to attain the target Hb concentration while receiving >300 IU/kg/wk (20 000 IU/wk) of epoetin or 1.5  µg/kg of darbepoetin alfa (100  µg/wk), or a continued need for such high dosages to maintain the target Revised EBPG, ERA-EDTA, 200468  
Initial ESA hyporesponsiveness:
• if no increase in Hb concentration from baseline after the first month of ESA treatment on appropriate weight-based dosing
Subsequent ESA hyporesponsiveness:
• classify patients as having acquired ESA hyporesponsiveness if after treatment with stable doses of ESA, they require 2 increases in ESA doses up to 50% beyond the dose at which they had maintained a stable Hb concentration
 
KDIGO, 20122  
Failure to achieve Hb target:
HD patients: despite 3000 IU dose of IV rHuEPO 3  ×  wk (9000 IU/wk) or 60  µg/wk of IV darbepoetin alfa once per week
PD patients: despite 6000 IU dose of SC rHuEPO once per week (6000 IU/wk) or 60  µg/wk of IV darbepoetin alfa once per week
Predialysis CKD patients: despite 6000 IU dose of SC HuEPO once per week (6000 IU/wk) 
Japanese Society for Dialysis Therapy, 201569  
Failure to achieve target Hb levels with epoetin doses >
• IV EPO 450 IU/kg/wk
• SC EPO: 300 IU/kg/wk
• darbepoetin dose >1.5 µg/kg/wk 
The Renal Association, UK, 2017 and 202070  
Weight-adjusted ERI
[weekly ESA dose/(body weight  ×  Hb)]
ESA resistance: ERI >15.4 IU/kg  ×  g/dL (quartile IV)a 
Panichi et al, RISCAVID study, 201152  
Definitions of ESA hyporesponsivenessOrganization or study
Failure to attain the target Hb concentration while receiving >300 IU/kg/wk (20 000 IU/wk) of epoetin or 1.5  µg/kg of darbepoetin alfa (100  µg/wk), or a continued need for such high dosages to maintain the target Revised EBPG, ERA-EDTA, 200468  
Initial ESA hyporesponsiveness:
• if no increase in Hb concentration from baseline after the first month of ESA treatment on appropriate weight-based dosing
Subsequent ESA hyporesponsiveness:
• classify patients as having acquired ESA hyporesponsiveness if after treatment with stable doses of ESA, they require 2 increases in ESA doses up to 50% beyond the dose at which they had maintained a stable Hb concentration
 
KDIGO, 20122  
Failure to achieve Hb target:
HD patients: despite 3000 IU dose of IV rHuEPO 3  ×  wk (9000 IU/wk) or 60  µg/wk of IV darbepoetin alfa once per week
PD patients: despite 6000 IU dose of SC rHuEPO once per week (6000 IU/wk) or 60  µg/wk of IV darbepoetin alfa once per week
Predialysis CKD patients: despite 6000 IU dose of SC HuEPO once per week (6000 IU/wk) 
Japanese Society for Dialysis Therapy, 201569  
Failure to achieve target Hb levels with epoetin doses >
• IV EPO 450 IU/kg/wk
• SC EPO: 300 IU/kg/wk
• darbepoetin dose >1.5 µg/kg/wk 
The Renal Association, UK, 2017 and 202070  
Weight-adjusted ERI
[weekly ESA dose/(body weight  ×  Hb)]
ESA resistance: ERI >15.4 IU/kg  ×  g/dL (quartile IV)a 
Panichi et al, RISCAVID study, 201152  

Shown are examples of regional guideline definitions based on numerical threshold values. Also shown is a hyporesponsiveness definition based on the ERI. In the RISCAVID study, IL-6 was the best predictor for ESA resistance. Patients in quartile 4 were defined as hyporesponders. In this study, quartile 4 was associated with worse cardiovascular outcome and higher mortality.

a

Thresholds to meet the definition of ESA hyporesponsiveness vary between different studies that use the ERI.

EBPG, European best practice guidelines; ERI, ESA resistance index; ERA-EDTA, European Renal Association-European Dialysis and Transplantation Association; KDIGO, Kidney Disease: Improving Global Outcomes; PD, peritoneal dialysis; rHuEPO, recombinant human erythropoietin; SC, subcutaneous.

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