Correction to: Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial
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Correction to: BMC Nephrol (2019) 20:90
https://doi.org/10.1186/s12882-019-1209-1
Following publication of the original article [1], the authors reported errors in the presentation of Tables 2, 4 and 5. Additionally, the authors reported an error in the last paragraph of the ‘Safety assessment’ section and an error in the first paragraph of the ‘Discussion’ section. In this Correction the incorrect and correct version of Tables 2, 4 and 5 and the incorrect and correct version of the sentences in the ‘Safety assessment’ and ‘Discussion’ section are shown.
Mean Hb levels (g/dL) and mean change in hemoglobin from Baseline to EOC – Dialysis, ITT Population (N = 126)
Statistics | ITT Population (N = 126) | PP Population (N = 93) | ||
|---|---|---|---|---|
Darbepoetin alfa (n = 63) | Erythropoietin alfa (n = 63) | Darbepoetin alfa (n = 47) | Erythropoietin alfa (n = 46) | |
Baseline | ||||
n | 56 | 53 | 47 | 46 |
Mean (SD) | 8.39 (0.90) | 8.80 (0.89) | 8.39 (0.85) | 8.72 (0.91) |
End of first evaluation visit | ||||
n | 55 | 51 | 47 | 46 |
Mean (SD) | 10.20 (1.74) | 10.61 (1.55) | 10.33 (1.42) | 10.90 (0.95) |
Within group comparison | ||||
p-value# | <.0001 | <.0001 | <.0001 | <.0001 |
Mean change | 1.84 | 1.85 | 1.94 | 2.18 |
95% CI | [1.36–2.32] | [1.37–2.33] | [1.48–2.40] | [1.84–2.53] |
Between group comparison | ||||
Mean change | −0.01 | −0.24 | ||
95% CI | [−0.68–0.66] | [− 0.81–0.32] | ||
p-value** | 0.9703 | 0.3985 | ||
Mean Hb levels (g/dL) and mean change in hemoglobin from Baseline to EOC – Dialysis, ITT Population (N = 126)
Statistics | ITT Population (N = 126) | PP Population (N = 93) | ||
|---|---|---|---|---|
Darbepoetin alfa (n = 63) | Erythropoietin alfa (n = 63) | Darbepoetin alfa (n = 47) | Erythropoietin alfa (n = 46) | |
Baseline | ||||
n | 56 | 53 | 47 | 46 |
Mean (SD) | 8.39 (0.90) | 8.80 (0.89) | 8.39 (0.85) | 8.72 (0.91) |
End of first evaluation visit | ||||
n | 55 | 51 | 47 | 46 |
Mean (SD) | 10.20 (1.74) | 10.61 (1.55) | 10.33 (1.42) | 10.90 (0.95) |
Within group comparison | ||||
p-value# | <.0001 | <.0001 | <.0001 | <.0001 |
Mean change | 1.84 | 1.85 | 1.94 | 2.18 |
95% CI | [1.36–2.32] | [1.37–2.33] | [1.48–2.40] | [1.84–2.53] |
Between group comparison | ||||
Mean change | −0.01 | −0.24 | ||
95% CI | [−0.68–0.66] | [− 0.81–0.32] | ||
p-value** | 0.9703 | 0.3985 | ||
Mean change in hemoglobin levels (g/dL) from baseline to week-4
Statistics | ITT Population (N = 126) | PP Population (N = 93) | ||
|---|---|---|---|---|
Darbepoetin alfa (n = 63) | Erythropoietin alfa (n = 63) | Darbepoetin alfa (n = 47) | Erythropoietin alfa (n = 46) | |
Baseline | ||||
n | 56 | 53 | 47 | 46 |
Mean (SD) | 8.39 (0.90) | 8.80 (0.89) | 8.39 (0.85) | 8.72 (0.91) |
Week-4 | ||||
n | 55 | 50 | 47 | 45 |
Mean (SD) | 8.66 (1.24) | 9.50 (1.81) | 8.68 (1.13) | 9.62 (1.71) |
Within group comparison | ||||
p-value* | 0.0566 | 0.0019 | 0.0473 | 0.0002 |
Mean change | 0.30 | 0.74 | 0.29 | 0.91 |
95% CI | [− 0.01–0.61] | [0.29–1.19] | [0.00–0.57] | [0.45–1.36] |
Between group comparison | ||||
Mean change | −0.44 | −0.62 | ||
95% CI | [−0.97–0.09] | [−1.14–0.10] | ||
p-value** | 0.1057 | 0.0209 | ||
Mean change in hemoglobin levels (g/dL) from baseline to week-4
Statistics | ITT Population (N = 126) | PP Population (N = 93) | ||
|---|---|---|---|---|
Darbepoetin alfa (n = 63) | Erythropoietin alfa (n = 63) | Darbepoetin alfa (n = 47) | Erythropoietin alfa (n = 46) | |
Baseline | ||||
n | 56 | 53 | 47 | 46 |
Mean (SD) | 8.39 (0.90) | 8.80 (0.89) | 8.39 (0.85) | 8.72 (0.91) |
Week-4 | ||||
n | 55 | 50 | 47 | 45 |
Mean (SD) | 8.66 (1.24) | 9.50 (1.81) | 8.68 (1.13) | 9.62 (1.71) |
Within group comparison | ||||
p-value* | 0.0566 | 0.0019 | 0.0473 | 0.0002 |
Mean change | 0.30 | 0.74 | 0.29 | 0.91 |
95% CI | [− 0.01–0.61] | [0.29–1.19] | [0.00–0.57] | [0.45–1.36] |
Between group comparison | ||||
Mean change | −0.44 | − 0.62 | ||
95% CI | [−0.97–0.09] | [−1.14–0.10] | ||
p-value** | 0.1057 | 0.0209 | ||
Time to initially attained target Hb level (10–12 g/dL) and proportion of patients attained target Hb level (10–12 g/dL) at EOC and EOM
Parameter | ITT Population (N = 126) | PP Population (N = 93) | ||
|---|---|---|---|---|
Darbepoetin alfa (n = 63) | Erythropoietin alfa (n = 63) | Darbepoetin alfa (n = 47) | Erythropoietin alfa (n = 46) | |
Number of weeks to initially attain target Hb | ||||
Median (95%CI) | 9.00 (7.00–11.00) | 7.00 (4.00–9.00) | 9.00 (7.00–10.00) | 7.00 (4.00–8.00) |
No. of Patients initially attained target Hb level | ||||
N (%) | 44 (78.57) | 43 (82.69) | 40 (85.10) | 41 (89.13) |
Hazard Ratio (95%CI) | 0.807 (0.53–1.23) | 0.778 (0.50–1.21) | ||
P Value | 0.3212 | 0.2608 | ||
No. of patients attained target Hb level at EOC | ||||
N (%) | 33 (52.38) | 31 (49.2) | 32 (68.08) | 32 (69.56) |
Odd ratios (95%CI) | 0.9559 (0.46–1.99) | 0.9410 (0.39–2.30) | ||
P value | 0.9038 | 0.8938 | ||
No. of patients maintained target Hb level at EOM | ||||
(%) | 24 (38.10) | 36 (57.14) | 15 (34.09) | 23 (57.50) |
Odd ratios (95%CI) | 0.5748 (0.26–1.25) | 0.4567 (0.17–1.22) | ||
P Value | 0.1621 | 0.1180 | ||
Time to initially attained target Hb level (10–12 g/dL) and proportion of patients attained target Hb level (10–12 g/dL) at EOC and EOM
Parameter | ITT Population (N = 126) | PP Population (N = 93) | ||
|---|---|---|---|---|
Darbepoetin alfa (n = 63) | Erythropoietin alfa (n = 63) | Darbepoetin alfa (n = 47) | Erythropoietin alfa (n = 46) | |
Number of weeks to initially attain target Hb | ||||
Median (95%CI) | 9.00 (7.00–11.00) | 7.00 (4.00–9.00) | 9.00 (7.00–10.00) | 7.00 (4.00–8.00) |
No. of Patients initially attained target Hb level | ||||
N (%) | 44 (78.57) | 43 (82.69) | 40 (85.10) | 41 (89.13) |
Hazard Ratio (95%CI) | 0.807 (0.53–1.23) | 0.778 (0.50–1.21) | ||
p-value | 0.3212 | 0.2608 | ||
No. of patients attained target Hb level at EOC | ||||
N (%) | 33 (52.38) | 31 (49.2) | 32 (68.08) | 32 (69.56) |
Odd ratios (95%CI) | 0.9559 (0.46–1.99) | 0.9410 (0.39–2.30) | ||
p-value | 0.9038 | 0.8938 | ||
No. of patients maintained target Hb level at EOM | ||||
(%) | 24 (38.10) | 36 (57.14) | 15 (34.09) | 23 (57.50) |
Odd ratios (95%CI) | 0.5748 (0.26–1.25) | 0.4567 (0.17–1.22) | ||
p-value | 0.1621 | 0.1180 | ||
Altogether, DA-α had a similar safety profile to that of EPO and no antibody formation was identified.
Altogether, DA-α had a similar safety profile to that of EPO and no anti-drug antibody formation was identified.
Evaluating the iron availability for erythropoeisis is crucial in treating anaemia patients with CKD.Iron deficiency can interfere with the response to EPO and DA-α and affecting the efficacy
Evaluating the iron availability for erythropoeisis is crucial in treating anaemia patients with CKD. Iron deficiency can interfere with the response to EPO and DA-α and affecting the efficacy
Reference
- 1.Sinha, et al. Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial. BMC Nephrol. 2019;20:90. https://doi.org/10.1186/s12882-019-1209-1.CrossRefPubMedPubMedCentralGoogle Scholar
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