Kidney Res Clin Pract > Volume 39(3); 2020 > Article |
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Conflicts of interest
James Jackson, Rebecca Moon, and Gary Milligan are employed by Adelphi Real World and declare no additional competing interests. Heleen van Haalen, Eirini Palaka, Alaster Allum, and James Sloand are full-time employees of AstraZeneca.
Authors’ contributions
James Jackson and Rebecca Moon participated in the conception and design of the study, and acquisition of data, analyzed and interpreted the data, and participated in manuscript writing and revision of drafts. Heleen van Haalen participated in the conception and design of the study, data interpretation, discussion of results and manuscript writing. James Sloand, Alaster Allum and Eirini Palaka participated in the interpretation of the data, discussion of results and manuscript writing. Gary Milligan participated in analyzing the data and reviewed the manuscript.
Characteristic | NDD patients | DD patients | |||||||||
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Overall | Hb < 10 g/dL | Hb 10 to 12 g/dL | Hb > 12 g/dL | P value | Overall | Hb < 10 g/dL | Hb 10 to 12 g/dL | Hb > 12 g/dL | P value | ||
Age (yr) | 0.008 | 0.034 | |||||||||
N | 704 | 115 | 441 | 148 | 348 | 168 | 155 | 25 | |||
Mean ± SD | 58.3 ± 9.9 | 57.8 ± 10.7 | 59.1 ± 9.4 | 56.2 ± 10.6 | 60.1 ± 10.7 | 60.4 ± 9.9 | 60.7 ± 11.0 | 54.8 ± 13.1 | |||
Sex | < 0.001 | 0.076 | |||||||||
N | 704 | 115 | 441 | 148 | 348 | 168 | 155 | 25 | |||
Male | 374 (53.1) | 41 (35.7) | 235 (53.3) | 98 (66.2) | 203 (58.3) | 104 (61.9) | 81 (52.3) | 18 (72.0) | |||
Employment status | 0.006 | 0.004 | |||||||||
N | 680 | 112 | 423 | 145 | 331 | 162 | 148 | 21 | |||
Full-time work | 93 (13.7) | 17 (15.2) | 42 (9.9) | 34 (23.4) | 30 (9.1) | 12 (7.4) | 10 (6.8) | 8 (38.1) | |||
Part-time work | 3 (0.4) | 0 (0.0) | 3 (0.7) | 0 (0.0) | 3 (0.9) | 1 (0.6) | 2 (1.4) | 0 (0.0) | |||
Homemaker/student | 62 (9.1) | 8 (7.1) | 44 (10.4) | 10 (6.9) | 23 (6.9) | 11 (6.8) | 11 (7.4) | 1 (4.8) | |||
Retired | 468 (68.8) | 76 (67.9) | 298 (70.4) | 94 (64.8) | 241 (72.8) | 123 (75.9) | 107 (72.3) | 11 (52.4) | |||
Unemployed | 54 (7.9) | 11 (9.8) | 36 (8.5) | 7 (4.8) | 34 (10.3) | 15 (9.3) | 18 (12.2) | 1 (4.8) | |||
Current estimated GFR (mL/min) | < 0.001 | N/A | N/A | N/A | N/A | N/A | |||||
N | 475 | 65 | 306 | 104 | |||||||
Mean ± SD | 33.2 ± 13.2 | 28.4 ± 12.4 | 32.1 ± 12.8 | 39.5 ± 12.6 | |||||||
Current CV riska | < 0.001 | 0.029 | |||||||||
N | 690 | 105 | 437 | 148 | 345 | 167 | 153 | 25 | |||
Very low | 39 (5.7) | 4 (3.8) | 19 (4.3) | 16 (10.8) | 5 (1.4) | 5 (3.0) | 0 (0.0) | 0 (0.0) | |||
Low | 107 (15.5) | 17 (16.2) | 60 (13.7) | 30 (20.3) | 28 (8.1) | 20 (12.0) | 6 (3.9) | 2 (8.0) | |||
Moderate | 323 (46.8) | 35 (33.3) | 217 (49.7) | 71 (48.0) | 83 (24.1) | 42 (25.1) | 35 (22.9) | 6 (24.0) | |||
High | 221 (32.0) | 49 (46.7) | 141 (32.3) | 31 (20.9) | 229 (66.4) | 100 (59.9) | 112 (73.2) | 17 (68.0) | |||
Rate of CKD progressionb | < 0.001 | N/A | N/A | N/A | N/A | N/A | |||||
N | 650 | 102 | 413 | 135 | |||||||
Slower than expected | 60 (9.2) | 6 (5.9) | 40 (9.7) | 14 (10.4) | |||||||
As expected | 418 (64.3) | 51 (50.0) | 269 (65.1) | 98 (72.6) | |||||||
Faster than expected | 172 (26.5) | 45 (44.1) | 104 (25.2) | 23 (17.0) | |||||||
Number of current symptomsc | < 0.001 | 0.243 | |||||||||
N | 692 | 115 | 439 | 138 | 346 | 168 | 155 | 23 | |||
Mean ± SD | 4.6 ± 2.3 | 5.8 ± 2.8 | 4.6 ± 2.2 | 3.6 ± 2.0 | 5.7 ± 2.6 | 5.9 ± 2.9 | 5.6 ± 2.2 | 4.9 ± 3.0 | |||
Median (range) | 4.0 (1.0-16.0) | 5.0 (1.0-16.0) | 5.0 (1.0-14.0) | 3.0 (1.0-10.0) | 5.5 (1.0-16.0) | 6.0 (1.0-16.0) | 6.0 (1.0-13.0) | 5.0 (1.0-12.0) | |||
Current symptomsc,* | |||||||||||
N | 704 | 115 | 441 | 148 | 348 | 168 | 155 | 25 | |||
Nocturia | 210 (29.8) | 51 (44.3) | 115 (26.1) | 44 (29.7) | < 0.001 | 102 (29.3) | 60 (35.7) | 37 (23.9) | 5 (20.0) | 0.037 | |
Oliguria | 379 (53.8) | 72 (62.6) | 247 (56.0) | 60 (40.5) | < 0.001 | 213 (61.2) | 103 (61.3) | 97 (62.6) | 13 (52.0) | 0.602 | |
Pruritus | 72 (10.2) | 16 (13.9) | 50 (11.3) | 6 (4.1) | 0.015 | 94 (27.0) | 50 (29.8) | 38 (24.5) | (24.0) | 0.536 | |
Fatigue/lack of energy | 489 (69.5) | 94 (81.7) | 316 (71.7) | 79 (53.4) | < 0.001 | 275 (79.0) | 128 (76.2) | 131 (84.5) | 16 (64.0) | 0.030 | |
Suppressed appetite | 317 (45.0) | 64 (55.7) | 10 (47.6) | 43 (29.1) | < 0.001 | 206 (59.2) | 101 (60.1) | 99 (63.9) | 6 (24.0) | < 0.001 | |
No. of concomitant conditions | < 0.001 | 0.238 | |||||||||
N | 704 | 115 | 441 | 148 | 348 | 168 | 155 | 25 | |||
Mean ± SD | 2.0 ± 2.0 | 3.2 ± 3.2 | 1.8 ± 1.5 | 1.6 ± 1.6 | 2.5 ± 2.1 | 2.6 ± 2.5 | 2.3 ± 1.8 | 3.0 ± 1.2 | |||
Median (range) | 1.0 (0-18.0) | 2.0 (0-18.0) | 1.0 (0-12.0) | 1.0 (0-8.0) | 2.0 (0-14.0) | 2.0 (0-14.0) | 2.0 (0-12.0) | 3.0 (1.0-6.0) | |||
Concomitant conditions† | |||||||||||
N | 703 | 114 | 441 | 148 | 348 | 168 | 155 | 25 | |||
Type 2 diabetes | 258 (36.7) | 48 (42.1) | 167 (37.9) | 43 (29.1) | 0.067 | 154 (44.3) | 77 (45.8) | 59 (38.1) | 18 (72.0) | 0.006 | |
Hypertension | 423 (60.2) | 68 (59.6) | 274 (62.1) | 81 (54.7) | 0.280 | 241 (69.3) | 105 (62.5) | 115 (74.2) | 21 (84.0) | 0.019 | |
CHD | 126 (17.9) | 39 (34.2) | 71 (16.1) | 16 (10.8) | < 0.001 | 80 (23.0) | 38 (22.6) | 33 (21.3) | 9 (36.0) | 0.265 | |
0.533 | |||||||||||
Osteoporosis/osteomalacia | 35 (5.0) | 13 (11.4) | 20 (4.5) | 2 (1.4) | < 0.001 | 37 (10.6) | 19 (11.3) | 17 (11.0) | 1 (4.0) | ||
Previously received a blood transfusion | 0.499 | 0.025 | |||||||||
N | 671 | 111 | 427 | 133 | 326 | 157 | 144 | 25 | |||
Yes | 16 (2.4) | 1 (0.9) | 12 (2.8) | 3 (2.3) | 146 (44.8) | 62 (39.5) | 67 (46.5) | 17 (68.0) | |||
No | 655 (97.6) | 110 (99.1) | 415 (97.2) | 130 (97.7) | 180 (55.2) | 95 (60.5) | 77 (53.5) | 8 (32.0) |
ANOVA, analysis of variance; CHD, coronary heart disease; CKD, chronic kidney disease; CV, cardiovascular; DD, dialysis-dependent; GFR, glomerular filtration rate; Hb, hemoglobin; NDD, non-dialysis-dependent; N/A, not available; SD, standard deviation.
aBased on physician opinion. bBased on physician selection from the options ‘Slower than expected’, ‘As expected’, ’Faster than expected’ and ‘Don’t know’ in response to the question “How would you describe the progression of this patient’s kidney disease?” cBased on symptoms indicated by the physicians to be currently present from a list of 24 symptoms, plus ‘Other (specify)’.
P values are the results of ANOVA or chi-square tests comparing differences across Hb levels, within NDD or DD. Missing data were not imputed; therefore, the base number of patients for analysis varies from variable to variable and is reported for each analysis. *P value ≤ 0.05 and reported by ≥ 25% of patients in either the NDD or DD group; †P value ≤ 0.03 and reported by ≥ 10% of patients in either the NDD or DD group.
Characteristic | NDD patients | DD patients | |||||||||
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Overall | Iron (oral or IV) only | ESA only | Iron (oral or IV) + ESA | P value | Overall | Iron (oral or IV) only | ESA only | Iron (oral or IV) + ESA | P value | ||
Age (yr) | 0.023 | 0.152 | |||||||||
N | 215 | 111 | 14 | 90 | 235 | 58 | 46 | 131 | |||
Mean ± SD | 59.7 ± 10.6 | 61.3 ± 9.8 | 62.3 ± 12.6 | 57.4 ± 10.9 | 61.2 ± 10.3 | 62.7 ± 10.7 | 62.7 ± 7.4 | 60.1 ± 10.9 | |||
Sex | 0.403 | 0.922 | |||||||||
N | 215 | 111 | 14 | 90 | 235 | 58 | 46 | 131 | |||
Male | 100 (46.5) | 56 (50.5) | 7 (50.0) | 37 (41.1) | 137 (58.3) | 35 (60.3) | 27 (58.7) | 75 (57.3) | |||
Employment status | 0.015 | 0.416 | |||||||||
N | 203 | 105 | 14 | 84 | 226 | 55 | 43 | 128 | |||
Full/part-time work | 26 (12.8) | 9 (8.6) | 0 (0.0) | 17 (20.2) | 19 (8.4) | 6 (10.9) | 0 (0) | 13 (10.2) | |||
Homemaker/student | 17 (8.4) | 13 (12.4) | 0 (0.0) | 4 (4.8) | 14 (6.2) | 5 (9.1) | 2 (4.7) | 7 (5.5) | |||
Retired | 146 (71.9) | 79 (75.2) | 12 (85.7) | 55 (65.5) | 172 (76.1) | 40 (72.7) | 37 (86.0) | 95 (74.2) | |||
Unemployed | 14 (6.9) | 4 (3.8) | 2 (14.3) | 8 (9.5) | 21 (9.3) | 4 (7.3) | 4 (9.3) | 13 (10.2) | |||
Current CV riska | 0.017 | 0.168 | |||||||||
N | 205 | 107 | 13 | 85 | 233 | 57 | 46 | 130 | |||
Very low | 7 (3.4) | 2 (1.9) | 0 (0.0) | 5 (5.9) | 4 (1.7) | 0 (0) | 0 (0) | 4 (3.1) | |||
Low | 26 (12.7) | 12 (11.2) | 0 (0.0) | 14 (16.5) | 20 (8.6) | 6 (10.5) | 0 (0) | 14 (10.8) | |||
Moderate | 84 (41.0) | 55 (51.4) | 4 (30.8) | 25 (29.4) | 50 (21.5) | 11 (19.3) | 12 (26.1) | 27 (20.8) | |||
High | 88 (42.9) | 38 (35.5) | 9 (69.2) | 41 (48.2) | 159 (68.2) | 40 (70.2) | 34 (73.9) | 85 (65.4) | |||
Rate of CKD progressionb | 0.021 | N/A | N/A | N/A | N/A | N/A | |||||
N | 199 | 99 | 14 | 86 | |||||||
Slower than expected | 17 (8.5) | 8 (8.1) | 0 (0.0) | 9 (10.5) | |||||||
As expected | 137 (68.8) | 77 (77.8) | 11 (78.6) | 49 (57.0) | |||||||
Faster than expected | 45 (22.6) | 14 (14.1) | 3 (21.4) | 28 (32.6) | |||||||
Number of current symptomsc | <0.001 | 0.083 | |||||||||
N | 215 | 111 | 14 | 90 | 235 | 58 | 46 | 131 | |||
Mean ± SD | 5.5 ± 2.6 | 4.6 ± 2.0 | 5.3 ± 1.3 | 6.6 ± 3.0 | 5.9 ± 2.7 | 5.2 ± 2.5 | 5.8 ± 2.6 | 6.2 ± 2.7 | |||
Median (range) | 5.0 (1.0-16.0) | 5.0 (1.0-14.0) | 5.5 (4.0-7.0) | 6.5 (1.0-16.0) | 6.0 (1.0-16.0) | 5.0 (1.0-16.0) | 5.5 (1.0-12.0) | 6.0 (1.0-13.0) | |||
Current symptomsc,* | |||||||||||
N | 215 | 111 | 14 | 90 | 235 | 58 | 46 | 131 | |||
Nocturia | 83 (38.6) | 42 (37.8) | 6 (42.9) | 35 (38.9) | 0.934 | 80 (34.0) | 14 (24.1) | 11 (23.9) | 55 (42.0) | 0.016 | |
Loin/flank (kidney) pain | 81 (37.7) | 31 (27.9) | 5 (35.7) | 45 (50.0) | 0.006 | 104 (44.3) | 23 (39.7) | 18 (39.1) | 63 (48.1) | 0.413 | |
Edema | 143 (66.5) | 62 (55.9) | 10 (71.4) | 71 (78.9) | 0.003 | 156 (66.4) | 27 (46.6) | 23 (50.0) | 106 (80.9) | <0.001 | |
Pruritus | 37 (17.2) | 16 (14.4) | 3 (21.4) | 18 (20.0) | 0.529 | 66 (28.1) | 8 (13.8) | 14 (30.4) | 44 (33.6) | 0.019 | |
Fatigue/lack of energy | 161 (74.9) | 72 (64.9) | 14 (100.0) | 75 (83.3) | < 0.001 | 185 (78.7) | 51 (87.9) | 33 (71.7) | 101 (77.1) | 0.106 | |
Suppressed appetite | 136 (63.3) | 65 (58.6) | 6 (42.9) | 65 (72.2) | 0.036 | 162 (68.9) | 42 (72.4) | 30 (65.2) | 90 (68.7) | 0.731 | |
No. of concomitant conditions | 0.025 | 0.001 | |||||||||
N | 215 | 111 | 14 | 90 | 235 | 58 | 46 | 131 | |||
Mean ± SD | 2.9 ± 2.7 | 2.6 ± 2.1 | 1.9 ± 1.4 | 3.5 ± 3.4 | 2.7 ± 2.4 | 2.4 ± 1.4 | 1.8 ± 1.2 | 3.2 ± 2.9 | |||
Median (range) | 2.0 (0-18.0) | 2.0 (0-12.0) | 2.0 (0-5.0) | 3.0 (0-18.0) | 2.0 (0-14.0) | 2.0 (0-6.0) | 2.0 (0-8.0) | 2.0 (0-14.0) | |||
Concomitant conditions† | |||||||||||
N | 214 | 110 | 14 | 90 | 235 | 58 | 46 | 131 | |||
Hypertension | 140 (65.4) | 74 (67.3) | 8 (57.1) | 58 (64.4) | 0.730 | 168 (71.5) | 40 (69.0) | 25 (54.3) | 103 (78.6) | 0.007 | |
Atherosclerosis | 26 (12.1) | 9 (8.2) | 0 (0.0) | 17 (18.9) | 0.025 | 18 (7.7) | 4 (6.9) | 2 (4.3) | 12 (9.2) | 0.555 | |
Osteoporosis/osteomalacia | 28 (13.1) | 15 (13.6) | 1 (7.1) | 12 (13.3) | 0.791 | 29 (12.3) | 6 (10.3) | 1 (2.2) | 22 (16.8) | 0.030 | |
Other GI conditions | 30 (14.0) | 6 (5.5) | 0 (0.0) | 24 (26.7) | < 0.001 | 8 (3.4) | 1 (1.7) | 0 (0.0) | 7 (5.3) | 0.164 |
ANOVA, analysis of variance; CKD, chronic kidney disease; CV, cardiovascular; DD, dialysis-dependent; ESA, erythropoietin-stimulating agent; GI, gastrointestinal; Hb, hemoglobin; IV, intravenous; NDD, non-dialysis-dependent; N/A, not available; SD, standard deviation.
aBased on physician opinion. bBased on physician selection from the options ‘Slower than expected’, ‘As expected’, ’Faster than expected’ and ‘Don’t know’ in response to the question “How would you describe the progression of this patient’s kidney disease?” cBased on symptoms indicated by the physicians to be currently present from a list of 24 symptoms, plus ‘Other (specify)’.
P values are the results of ANOVA or chi-square tests comparing differences in anemia treatments within NDD or DD. Missing data were not imputed; therefore, the base number of patients for analysis varies from variable to variable and is reported for each analysis. *P value ≤ 0.05 and reported by ≥ 25% of patients in either NDD or DD group; †P value ≤ 0.05 and reported by ≥ 10% of patients in either NDD or DD group.
Overall | Treated and Hb ≥ 10 g/dL | Treated and Hb < 10 g/dL | P value | |
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Patient age (yr) | 0.327 | |||
N | 572 | 321 | 251 | |
Mean ± SD | 59.9 ± 10.3 | 60.3 ± 10.2 | 59.5 ± 10.5 | |
Sex | 0.674 | |||
N | 572 | 321 | 251 | |
Male | 302 (52.8) | 172 (53.6) | 130 (51.8) | |
Female | 270 (47.2) | 149 (46.4) | 121 (48.2) | |
Time since CKD diagnosis (yr) | 0.102 | |||
N | 556 | 313 | 243 | |
Mean ± SD | 3.6 ± 3.7 | 3.3 ± 3.8 | 3.8 ± 3.7 | |
Current ferritin (ng/mL) | 0.017 | |||
N | 356 | 174 | 182 | |
Mean ± SD | 137.1 ± 179.0 | 113.9 ± 116.0 | 159.2 ± 221.4 | |
Current TSAT and ferritin levelsa | 0.057 | |||
N | 572 | 321 | 251 | |
TSAT < 30% & ferritin < 500 ng/mL | 179 (31.3) | 111 (34.6) | 68 (27.1) | |
Current serum albumin (g/L) | 0.034 | |||
N | 426 | 231 | 195 | |
Mean ± SD | 33.4 ± 8.2 | 33.8 ± 7.3 | 33.0 ± 9.3 | |
Concomitant conditions | ||||
N | 571 | 321 | 250 | |
UTIs | 12 (2.1) | 3 (0.9) | 9 (3.6) | 0.038 |
Type 2 diabetes | 229 (40.1) | 117 (36.4) | 112 (44.8) | 0.048 |
Hypertension | 380 (66.5) | 225 (70.1) | 155 (62.0) | 0.049 |
Atherosclerosis | 51 (8.9) | 22 (6.9) | 29 (11.6) | 0.055 |
Arrhythmia | 46 (8.1) | 19 (5.9) | 27 (10.8) | 0.043 |
Unstable angina | 17 (3.0) | 5 (1.6) | 12 (4.8) | 0.027 |
Retinopathy | 39 (6.8) | 12 (3.7) | 27 (10.8) | 0.001 |
Erectile dysfunction | 11 (1.9) | 3 (0.9) | 8 (3.2) | 0.066 |
Gout/hyperuricemia | 9 (1.6) | 1 (0.3) | 8 (3.2) | 0.012 |
Arthritis | 25 (4.4) | 7 (2.2) | 18 (7.2) | 0.006 |
GI conditions | 41 (7.2) | 16 (5.0) | 25 (10.0) | 0.023 |
No. of concomitant conditions | 0.004 | |||
N | 572 | 321 | 251 | |
Mean ± SD | 2.6 ± 2.4 | 2.4 ± 1.8 | 3.0 ± 2.9 | |
Rate of CKD progressionb | 0.003 | |||
N | 268 | 84 | 184 | |
Slower than expected | 22 (8.2) | 6 (7.1) | 16 (8.7) | |
As expected | 174 (64.9) | 44 (52.4) | 130 (70.7) | |
Faster than expected | 72 (26.9) | 34 (40.5) | 38 (20.7) | |
Current estimated GFRb | 0.105 | |||
N | 166 | 117 | 49 | |
Mean ± SD | 29.3 ± 12.1 | 30.3 ± 12.2 | 26.9 ± 11.7 |
CKD, chronic kidney disease; DD, dialysis-dependent; GFR, glomerular filtration rate; GI, gastrointestinal; Hb, hemoglobin; NDD, non-dialysis-dependent; SD, standard deviation; TSAT, transferrin saturation; UTI, urinary tract infection.
aThis variable describes the proportion of patients with TSAT < 30% and ferritin < 500 ng/mL out of all patients. bThese variables were analyzed for NDD patients only as eGFR and CKD progression are less relevant among the DD population.
P values are the results of Student’s t test, Fisher’s exact test, or chi-square tests comparing between dichotomized Hb levels for treated patients only. Missing data were not imputed; therefore, the base number of patients for analysis varies from variable to variable and is reported for each analysis.