Table 1.
Baseline Demographics and Disease Characteristics
| Characteristics | Pooled KALM-1 and KALM-2 |
|
|---|---|---|
| Placebo n = 425 | Difelikefalin n = 426 | |
| Age, mean ± SD, years | 58.3 ± 13.5 | 59.1 ± 12.4 |
| Male, n (%) | 258 (60.7) | 249 (58.5) |
| Ethnicity, n (%) | ||
| Not Hispanic or Latino | 287 (67.5) | 287 (67.4) |
| Hispanic or Latino | 136 (32.0) | 133 (31.2) |
| Race, n (%) | ||
| White | 262 (61.6) | 255 (59.9) |
| Black or African American | 114 (26.8) | 135 (31.7) |
| Othera | 49 (11.5) | 36 (8.5) |
| Region, n (%) | ||
| United States | 322 (75.8) | 335 (78.6) |
| Eastern Europe | 60 (14.1) | 54 (12.7) |
| Western Europe | 31 (7.3) | 29 (6.8) |
| Asia | 12 (2.8) | 8 (1.9) |
| Prescription dry body weight, mean ± SD, kg | 82.4 ± 20.6 | 83.4 ± 20.1 |
| Years since diagnosis of ESKD, median (IQR) | 4.1 (5.3) | 3.8 (4.8) |
| Etiology of CKD,b n (%) | ||
| Diabetes | 206 (48.5) | 225 (52.8) |
| Hypertension | 138 (32.5) | 122 (28.6) |
| Glomerulonephritis | 16 (3.8) | 18 (4.2) |
| Cystic kidney | 15 (3.5) | 14 (3.3) |
| Other | 50 (11.8) | 47 (11.0) |
| Years on chronic HD, median (IQR) | 3.9 (5.0) | 3.5 (4.8) |
| Duration of pruritus, median (IQR), years | 2.5 (3.2) | 2.1 (3.2) |
| Blood chemical testingc | ||
| Bilirubin, mean ± SD, mg/dL | 0.5 ± 0.3 | 0.5 ± 0.6 |
| Calcium, mean ± SD, mg/dL | 8.4 ± 0.8 | 8.8 ± 0.8 |
| Phosphate, mean ± SD, mg/dL | 5.6 ± 2.2 | 5.6 ± 1.9 |
| Baseline use of an anti-itch medication, n (%) | 163 (38.4) | 159 (37.3) |
| Most commonly used (>2%) anti-itch medications at baseline, n (%) | ||
| Diphenhydramine | 100 (23.5) | 104 (24.4) |
| Hydroxyzine | 52 (12.2) | 42 (9.9) |
| Hydrocortisone | 16 (3.8) | 11 (2.6) |
| Cetirizine | 10 (2.4) | 7 (1.6) |
| Clemastine | 10 (2.4) | 7 (1.6) |
| Presence of selected medical conditions,d n (%) | 65 (15.3) | 67 (15.7) |
| WI-NRS score, mean ± SD | 7.2 ± 1.5 | 7.2 ± 1.4 |
| Skindex-10 total score, mean ± SD | 36.0 ± 15.1 | 35.8 ± 14.7 |
| 5-D Itch total score, mean ± SD | 16.9 ± 3.5 | 16.8 ± 3.5 |
Note: Percentages are based on the number of participants in each group.
Abbreviations: CKD, chronic kidney disease; ESKD, end-stage kidney disease; HD, hemodialysis; IQR, interquartile range; SD, standard deviation; WI-NRS, Worst Itching Intensity Numerical Rating Scale.
Includes participants who identified as American Indian or Alaska native (placebo, n = 6; difelikefalin, n = 7), Asian (placebo, n = 27; difelikefalin, n = 18), native Hawaiian or other Pacific Islander (placebo, n = 7; difelikefalin, n = 3), unknown (placebo, n = 2; difelikefalin, n = 1), and other (placebo, n = 7; difelikefalin, n = 7).
Diabetes values include patients with diabetes alone; diabetes and hypertension; diabetes, hypertension, and other; or diabetes and other. Hypertension values include patients with hypertension alone or hypertension and other. Glomerulonephritis values include patients with glomerulonephritis alone or glomerulonephritis and other.
Conversion factors for units were as follows: for bilirubin, mg/dL to μmol/L, ×17.1; for calcium, mg/dL to mmol/L, ×0.2495; and for phosphate, mg/dL to mmol/L, ×0.3229.
Specific medical condition values include patients with a history of fall or fracture (related to fall); confused state, mental status change, altered mental status, or disorientation; and gait disturbance or movement disorder.