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Table 1 Demographics and baseline characteristics of the per-protocol set

From: A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-Alfa) vs. Eprex® in patients with anaemia of chronic renal failure

 

PDA-10

(N = 136)

Eprex®

(N = 120)

P value

Mean age (range), years

54.09 (11.26)

51.01 (14.04)

NS

Sex [n (%)]

 Male

85.00 (62.50)

76.00 (63.33)

NS

 Female

51.00 (37.50)

44.00 (36.67)

Race/Ethnicity [n (%)]

 Korean

35.00 (25.74)

27.00 (22.50)

NS

 Malaysian

101.00 (74.26)

93.00 (77.50)

 Mean weight (kg)

64.48 (14.02)

63.49 (12.66)

 Mean BMI (kg/m2)

24.86 (4.58)

24.34 (4.38)

 Mean duration of renal anaemia (range) (month)

64.46 (56.18)

57.58 (49.67)

NS

 Mean duration of ESKD (range) (month)

66.01(59.84)

60.16 (52.34)

 Mean baseline Hb (range) (g/dl)

11.01 (0.58)

11.00(0.59)

 Mean baseline dosage of epoetin (range) (IU/week)

107.52 (69.18)

114.58 (73.86)

 Mean baseline ferritin (range) (ng/ml)

692.39 (686.85)

740.18 (602.42)

 Mean baseline transferrin saturation (range) (%)

34.49(20.61)

31.24 (13.49)

  1. BMI body mass index, ESKD end stage kidney disease, Hb haemoglobin, IU international unit