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BMC Nephrology

, 20:415 | Cite as

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

  • Shubhadeep D. Sinha
  • Vamsi Krishna Bandi
  • Bala Reddy Bheemareddy
  • Pankaj ThakurEmail author
  • Sreenivasa Chary
  • Kalpana Mehta
  • Vikranth Reddy Pinnamareddy
  • Rajendra Pandey
  • Subhramanyam Sreepada
  • Santosh Durugkar
Open Access
Correction
  • 162 Downloads

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.

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:
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

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:
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

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:
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 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. 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

Copyright information

© The Author(s). 2019

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Authors and Affiliations

  • Shubhadeep D. Sinha
    • 1
  • Vamsi Krishna Bandi
    • 1
  • Bala Reddy Bheemareddy
    • 1
  • Pankaj Thakur
    • 1
    Email author
  • Sreenivasa Chary
    • 1
  • Kalpana Mehta
    • 2
  • Vikranth Reddy Pinnamareddy
    • 3
  • Rajendra Pandey
    • 4
  • Subhramanyam Sreepada
    • 5
  • Santosh Durugkar
    • 6
  1. 1.Clinical Development and Medical Affairs, Hetero Group, Hetero CorporateHyderabadIndia
  2. 2.Department of NephrologyB.L.Y Nair HospitalMumbaiIndia
  3. 3.Care HospitalsHyderabadIndia
  4. 4.Department of NephrologyInstitute of Post Graduate Medical Education and Research KolkataKolkataIndia
  5. 5.Sri Raghavendra HospitalHyderabadIndia
  6. 6.Ashwini Hospital and Ramakanth Heart Care CenterNandedIndia

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