Table 1. Baseline Characteristics of Participants in a Study of the Effect of Oral Methylprednisolone on Kidney Function Decline in Patients With IgA Nephropathy.
| Characteristics | No. (%)a | |
|---|---|---|
| Methylprednisolone (n = 257) | Placebo (n = 246) | |
| Age, median (IQR), y | 35.6 (29.4-46.3) | 36.6 (29.0-45.9) |
| Sex | ||
| Men | 155 (60) | 150 (61) |
| Women | 102 (40) | 96 (39) |
| Race/ethnicityb | ||
| Chinese | 195 (76) | 184 (75) |
| Japanese | 0 | 1 (0.4) |
| Mixed | 0 | 1 (0.4) |
| Other Eastern Asian | 1 (0.4) | 0 |
| South Asian | 30 (12) | 33 (13) |
| Southeast Asian | 18 (7) | 15 (6) |
| White/European | 13 (5) | 12 (5) |
| BMI, median (IQR) | 24.2 (21.6-26.7) | 24.7 (22.0-28.0) |
| Smoking history | ||
| Previous | 39 (15) | 27 (11) |
| Current | 19 (7) | 23 (9) |
| Medical historyc | ||
| Hypertension | 128 (50) | 113 (46) |
| Macrohematuria | 42 (16) | 38 (15) |
| Previous corticosteroids | 18 (7) | 10 (4) |
| Previous other immunosuppressant | 17 (7) | 12 (5) |
| Diabetes | 7 (3) | 10 (4) |
| Family history of IgA nephropathy | 3 (1) | 9 (4) |
| Tonsillectomy | 2 (0.8) | 1 (0.4) |
| Blood pressure, median (IQR), mm Hg | ||
| Systolic | 123.8 (115.0-132.5) | 125.0 (115.5-131.0) |
| Diastolic | 80.0 (73.5-85.0) | 80.0 (74.0-86.0) |
| Laboratory findings, median (IQR) | ||
| eGFR, mL/min per 1.73 m2d | 56.1 (43.2-75.0) | 59.0 (42.0-77.6) |
| Urine protein, g/de | 1.99 (1.36-3.09) | 1.93 (1.38-2.88) |
| Time since kidney biopsy, median (IQR), mo | 5 (4-11) | 5 (3-14) |
| Histology on kidney biopsy, No./total No. (%)f | ||
| Mesangial hypercellularity (M1) | 147/252 (58) | 148/241 (61) |
| Segmental glomerulosclerosis (S1) | 172/252 (68) | 164/241 (68) |
| Endocapillary hypercellularity (E1) | 72 (28) | 55 (22) |
| Tubular atrophy/interstitial fibrosis (T) | ||
| T0: 0%-25% | 123/252 (48.8) | 118/241 (49.0) |
| T1: 26%-50% | 92/252 (36.5) | 95/241 (39.4) |
| T2: >50% | 37/252 (14.7) | 28/241 (11.6) |
| Medication | ||
| ACE inhibitors | 140 (54.5) | 128 (52.0) |
| ARBs | 119 (46.3) | 120 (48.8) |
| Dose of ACE inhibitor or ARB | ||
| No ACE or ARB received | 0 | 1 (0.4) |
| <50% of maximum labeled doseg | 30 (11.7) | 35 (14.2) |
| ≥50% of maximum labeled doseg | 222 (86.4) | 201 (81.7) |
| Received but dose unknown | 5 (1.9) | 9 (3.7) |
| Calcium channel blocker | ||
| Dihydropyridine | 44 (17.1) | 41 (16.7) |
| Nondihydropyridine | 13 (5.1) | 17 (6.9) |
| β and α blocker | 21 (8.2) | 20 (8.1) |
| Diuretic | 20 (7.8) | 21 (8.5) |
| Mineralocorticoid receptor antagonist | 4 (1.6) | 11 (4.5) |
| Nitrates | 2 (0.8) | 0 |
| Centrally acting | 5 (1.9) | 2 (0.8) |
Abbreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared).
Percentages may not total 100 because of rounding.
Participant self-reported ethnicity was listed as 13 categories in the study case report form. There were no participants of African, Australian (Aboriginal), Arabic, Maori/Polynesian, Japanese, or North American Indian ancestry. South Asian refers to participants from India; Southeast Asian refers to participants from Malaysia. One participant reported as mixed race and 1 participant reported as Other Eastern Asian.
Medical history was reported by the patients.
Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration formula; normal values were 90 mL/min/1.73 m2 or greater.
Normal values of urine protein excretion were less than 0.2 g/d.
Histological findings were scored by Oxford Classification (MEST) and reviewed by each site. The median (IQR) time between biopsy and randomization was 5 (4-13) months. T score relates to the proportion of the kidney biopsy affected by tubular atrophy/interstitial fibrosis and is divided into 3 categories, as listed.
Maximum labeled dose is based on individual country local practice. All participants received stable maximum tolerated dose of ACE inhibitors or ARBs for at least 12 weeks.