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 |
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 |
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 |
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 |
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 |
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