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.
Table 2.
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 | ||
n number of subject at each visit, N total number of subjects, ITT Intent to treat, PP Per protocol, Hb Hemoglobin
# p-values were obtained using Paired t Test for mean (two tailed, α = 0.05)
** p-values were obtained using Unpaired t Test for mean change (two tailed, α = 0.05)
Note: Patients taken where Hb < 10 at Screening
Table 4.
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 | ||
n number of subject at each visit; N total number of subjects, ITT Intent to treat, PP Per protocol, Hb Hemoglobin
* p-value were obtained using Paired t Test for mean (two tailed, α = 0.05)
**p-value were obtained using Unpaired t Test for mean change (two tailed, α = 0.05)
Note: Patients taken where Hb < 10 at Screening
Table 5.
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 | ||
EOC End of correction, EOM End of maintenance, ITT Intent to treat, PP Per protocol, Hb Hemoglobin
Originally Table 2 was published as:
Table 2.
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 | ||
N number of subject at each visit, N total number of subjects, ITT Intent to treat, PP Per protocol
# p-values were obtained using Paired t Test for mean (two tailed, α 0.05)
** p-values were obtained using Unpaired t Test for mean change (two tailed, α = 0.05)
Note: Patients taken where Hb < 10 at Screening
The correct version of Table 2, with the corrected sections indicated in bold:
Originally Table 4 was published as:
Table 4.
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 | ||
n number of subject at each visit; N total number of subjects, ITT Intent to treat, PP Per protocol
* p-value were obtained using Paired t Test for mean (two tailed, a = 0.05)
**p-value were obtained using Unpaired t Test for mean change (two tailed, a = 0.05)
Note: Patients taken where Hb < 10 at Screening
The correct version of Table 4, with the corrected sections indicated in bold:
Originally Table 5 was published as:
Table 5.
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 | ||
EOC End of correction, EOM End of maintenance, ITT Intent to treat, PP Per protocol, Hb Hemoglobin
The correct version of Table 5, with the corrected sections indicated in bold:
Originally the last paragraph of the ‘Safety assessment’ section was published as:
Altogether, DA-α had a similar safety profile to that of EPO and no antibody formation was identified.
The correct presentation of the last paragraph of the ‘Safety assessment’ section, with the corrected words indicated in bold:
Altogether, DA-α had a similar safety profile to that of EPO and no anti-drug antibody formation was identified.
Originally two sentences in the first paragraph of the ‘Discussion’ section were published as:
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
The correct presentation of two sentences in the first paragraph of the ‘Discussion’ section, with the corrected words indicated in bold:
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. doi: 10.1186/s12882-019-1209-1. [DOI] [PMC free article] [PubMed] [Google Scholar]