Table 1. Baseline Demographic Characteristics for the Modified Intention-to-Treat Populationa.
| Characteristic | Prednisolone (n = 134) | Placebo (n = 137) |
|---|---|---|
| Background treatment regimenb | ||
| No long-term treatment | 31 (23.1) | 31 (22.6) |
| Long-term maintenance prednisolone | 40 (30.0) | 34 (24.8) |
| Other immunosuppressant therapy plus long-term maintenance prednisolone | 43 (32.1) | 48 (35.0) |
| Other immunosuppressant therapy only | 20 (14.9) | 24 (17.5) |
| Age, mean (SD), y | 7.7 (3.6) | 7.5 (3.5) |
| Sex | ||
| Male | 83 (61.9) | 91 (66.4) |
| Female | 51 (38.0) | 46 (33.6) |
| BMI percentile | ||
| Median (IQR) | 84.1 (63.7-96.9) | 86.4 (68.4-97.0) |
| Underweight (<5th percentile) | 0 | 0 |
| Healthy (5th-84th percentile) | 69 (51.5) | 64 (46.7) |
| Overweight (85th-94th percentile) | 24 (17.9) | 30 (21.9) |
| Obese (≥95th percentile) | 41 (30.6) | 43 (31.4) |
| Prednisolone dose on alternate days, mg | 9.2 (3.7) | 8.4 (3.1) |
| Race and ethnicityc | ||
| South Asian | 30 (22.4) | 28 (20.4) |
| White | 96 (71.6) | 92 (67.2) |
| Other or unknown | 8 (6.0) | 17 (12.4) |
| Age at diagnosis of nephrotic syndrome, mean (SD), y | 4.4 (2.5) | 4.4 (2.8) |
| Time to randomization, median (IQR) [range], d | ||
| Time to last relapse | 90 (58-143) [14-280] | 87 (58-126) [7-280] |
| Second last relapse | 209.5 (153-287) [42-363] | 189 (146-252) [36-365] |
Abbreviation: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared).
a
Data are presented as number (percentage) of patients unless otherwise indicated.
b
Minimization variable.
c
Ethnicity was self-reported from an extended list and subsequently rationalized into broad categories as displayed. The broad category definitions according to self-reported ethnicity are given in eTable 5 in Supplement 2.