Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD

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Figure 1.
Patient disposition. ESA, erythropoiesis-stimulating agent.
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Figure 2.
Hemoglobin (Hb) was maintained within the target range in the higher conversion factor group during the core trial period. Mean Hb values with 95% confidence intervals are shown. Dashed lines indicate target range.
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Figure 3.
Changes in hemoglobin (Hb) were comparable in subgroups by age or previous ESA use in the higher conversion factor group. Mean changes with 95% confidence intervals are shown. Dashed lines indicate target range.
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Figure 4.
Reticulocytes showed expected cyclical variation with no overall increase. Mean absolute counts with 95% confidence intervals are shown.
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Figure 5.
Hemoglobin (Hb) concentrations were maintained in both groups in patients who entered the extension phase. Mean Hb values with 95% confidence intervals are shown. Dashed lines indicate the target range.

Table 1.

Baseline demographic and disease characteristics

Characteristic	Group 1, Intermediate Conversion Factor, n=16	Group 2, Higher Conversion Factor, n=48	Total, n=64
Conversion factor used	4 µg every 4 wk for each weekly dose of 250 IU epoetin or 1.1 µg darbepoetin	4 µg every 4 wk for each weekly dose of 125 IU epoetin or 0.55 µg darbepoetin
Boys, n (%)	11 (69)	23 (48)	34 (53)
Mean age, yr (range)	11.3 (7–16)	13.0 (6–17)	12.6 (6–17)
Age 6–11 yr, n (%)	9 (56)	16 (33)	25 (39)
Age 12–17 yr, n (%)	7 (44)	32 (67)	39 (61)
Mean hemoglobin, g/dl	11.3±0.5	11.3±0.5	11.1±0.5
Mean weight, kg	33±12	39±14	38±14
Mean height, cm	139±18	144±17	143±17
Mean Z score for height	−1.55±1.84	−1.78±1.41	−1.72±1.51
Mean Kt/V urea	1.57±0.38	1.60±0.41	1.60±0.40
Vascular access arteriovenous fistula, n (%)	13 (81)	31 (65)	44 (69)
Race, n (%)
White	11 (69)	35 (73)	46 (72)
Black	1 (6)	1 (2)	2 (3)
Asian	2 (13)	5 (10)	7 (11)
Other	2 (13)	7 (15)	9 (14)
Etiology of CKD, n (%)
Hereditary nephropathy	3 (19)	13 (27)	16 (25)
Hypoplastic/dysplastic kidneys	2 (13)	12 (25)	14 (22)
Obstructive uropathy	4 (25)	8 (17)	12 (19)
Other GN	2 (13)	7 (15)	9 (14)
Systemic disease	1 (6)	6 (13)	7 (11)
Reflux nephropathy	0 (0)	5 (10)	5 (8)
FSGS	3 (19)	1 (2)	4 (6)
Median years from first dialysis	1.5 (1.1–3.4)	1.2 (0.5–4.1)	1.3 (0.5–3.7)
Median years from first ESA	1.8 (1.2–3.7)	1.2 (0.5–3.1)	1.3 (0.5–3.1)
Median previous ESA dose
Darbepoetin alfa, µg/wk	17.5 (9–25)	20.0 (10–20)	20.0 (10–20)
Epoetin alfa/beta, IU/wk	4500 (2250–7500)	6000 (4000–6000)	6000 (3000–6000)

Mean values are shown ±1 SD; median values are shown with interquartile range. ESA, erythropoiesis-stimulating agent.

Table 2.

Ratio of the dose during the evaluation period to the first dose

Dose Ratio, Median (Interquartile Range)	n	Group 1 (Intermediate Conversion Factor)	n	Group 2 (Higher Conversion Factor)
All patients	12	1.59 (1.19–2.47)	36	1.00 (0.66–1.52)
Age group
Patients aged 6–11 yr	6	1.81 (0.76–2.50)	11	1.25 (1.00–1.60)
Patients aged 12–17 yr	6	1.59 (1.25–2.44)	25	0.98 (0.62–1.48)
Previous ESA treatment
Darbepoetin alfa	6	1.82 (1.17–2.44)	19	1.00 (0.75–1.57)
Epoetin alfa/beta	6	1.59 (1.25–2.50)	17	1.00 (0.60–1.25)

Table 3.

Results of safety monitoring

Event	Group 1 (Intermediate Conversion Factor)	Group 2 (Higher Conversion Factor)	Total
Core study period	n=16	n=48	n=64
Adverse event, n (%)	12 (75)	37 (77)	49 (77)
Serious adverse event, n (%)	4 (25)	12 (25)	16 (25)
Fatal adverse event, n (%)	0	1 (2)	1 (2)
Withdrawal due to adverse event, n (%)	0	1 (2)	1 (2)
Blood transfusions, n (%)	1 (11)	2 (4)	3
Incidence of individual adverse events, n (%)^a
Headache	1 (6)	8 (17)	9 (14)
Nasopharyngitis	0 (0)	9 (19)	9 (14)
Hypertension	1 (6)	7 (15)	8 (13)
Vomiting	2 (13)	4 (8)	6 (9)
Abdominal pain	1 (6)	3 (6)	4 (6)
Bronchitis	1 (6)	3 (6)	4 (6)
Extension period	n=9	n=28	n=37
Adverse event, n (%)	4 (44)	23 (82)	27 (73)
Serious adverse event, n (%)	1 (11)	8 (28)	9 (24)
Fatal adverse event, n (%)	0 (0)	0 (0)	0 (0)
Withdrawal due to adverse event, n (%)	0 (0)	0 (0)	0 (0)
Incidence of individual adverse events, n (%)^a
Nasopharyngitis	0 (0)	7 (25)	7 (19)
Headache	0 (0)	6 (21)	6 (16)
Hypertension	0 (0)	5 (18)	5 (14)
Bronchitis	1 (11.1)	2 (7)	3 (8)
Pharyngitis	0 (0)	3 (11)	3 (8)