Table 1.
Baseline characteristics of adult patients with MCNS in each treatment group (modified ITT)
| Patient Characteristics | Tacrolimus and Low-Dose Steroid (n=67) | High-Dose Steroid (n=69) |
|---|---|---|
| Sex, men, n (%) | 45 (67.2) | 40 (58.0) |
| Age, yr | 41.8±16.7 | 42.2±17.8 |
| Median (min, max) | 40 (18, 78) | 39 (16, 79) |
| (95% CI) | (37.7 to 45.9) | (37.9 to 46.5) |
| Weight, kg | 68.9±13.9 | 64.4±13.0 |
| Median (min, max) | 67 (47, 129.8) | 63.2 (42, 115) |
| (95% CI) | (65.5 to 72.2) | (61.3 to 67.5) |
| BP, mm Hg | ||
| Systolic | 122.2±14.4 | 121.5±13.2 |
| Median (min, max) | 122 (96, 168) | 120.5 (99, 183) |
| (95% CI) | (118.7 to 125.7) | (118.3 to 124.7) |
| Diastolic | 76.1±9.0 | 75.8±9.9 |
| Median (min, max) | 75 (58, 97) | 75 (58, 122) |
| (95% CI) | (73.9 to 78.3) | (73.4 to 78.2) |
| Serum albumin, g/dl | 2.3±0.7 | 2.4±0.8 |
| Median (min, max) | 2.2 (1.1, 4.0) | 2.3 (0.9, 4.1) |
| (95% CI) | (2.2 to 2.5) | (2.3 to 2.6) |
| Creatinine, mg/dl | 0.9±0.3 | 0.9±0.4 |
| Median (min, max) | 0.84 (0.45, 1.8) | 0.82 (0.34, 2.4) |
| (95% CI) | (0.8 to 1.0) | (0.8 to 1.0) |
| MDRD eGFR, ml/min per 1.73 m2a | 95.9±33.7 | 97.6±39.6 |
| Median (min, max) | 90.2 (34.6, 216.6) | 93.3 (34.0, 240.8) |
| (95% CI) | (87.7 to 104.1) | (88.1 to 107.2) |
| UPCR, g protein/g creatinine | 8.4±3.9 | 9.2±6.5 |
| Median (min, max) | 7.58 (3.3, 20.0) | 7.8 (1.1, 34.8) |
| (95% CI) | (7.4 to 9.3) | (7.6 to 10.7) |
| Blood glucose, mg/dl | 100.9±22.0 | 100.8±16.2 |
| Median (min, max) | 96 (77, 203) | 99 (65, 152) |
| (95% CI) | (95.6 to 106.3) | (96.9 to 104.7) |
| LDL cholesterol, mg/dl | 243.9±117.8 | 217.7±102.7 |
| Median (min, max) | 235.5 (27.0, 524.0) | 195 (72.2, 531.0) |
| (95% CI) | (214.5 to 273.4) | (192.3 to 243.1) |
| MCNS first presentation/relapse, n | 32/35 | 36/33 |
Values expressed as mean ± SD, unless stated otherwise. MDRD eGFR, Modification of Diet in Renal Disease estimated glomerular filtration rate.
a
Four patients had an eGFR <45 ml/min per 1.73 m2 at baseline, and eGFR improved by Week 8 in three of these patients (follow-up data missing for the fourth patient).