Table 2.
Baseline characteristics of participants in primary membranous nephropathy trials
| Treatment group | STARMEN (n = 86) |
RI-CYCLO (n = 74) |
MENTOR (n = 130) |
GEMRITUX (n = 75) |
||||
|---|---|---|---|---|---|---|---|---|
| TAC-RTX (n = 43) |
GC-CYC (n = 43) |
RTX (n = 37) |
GC-CYC (n = 37) |
RTX (n = 65) |
CsA (n = 65) |
RTX (n = 37) |
NIAT (n = 38) |
|
| Characteristics | ||||||||
| Age at randomization, years | 55.2 (10.8) | 56.2 (12) | 54 (14) | 55 (17) | 51.9 (12.6) | 52.2 (12.4) | 53 (42–63) | 58.5 (43–64) |
| Male sex | 31 (72) | 24 (55) | 28 (76) | 25 (68) | 47 (72) | 53 (82) | 28 (76) | 24 (63) |
| Weight, kg | 80 (15) | 76.9 (17) | 75 (11) | 76 (15) | 96 (23) | 90 (20) | 76 (70–85) | 76.5 (67–85) |
| History of hypertension | NA | 22 (59) | 26 (37) | NA | NA | |||
| Blood pressure, mmHg | ||||||||
| Systolic | 127.1 (14) | 129.4 (17.7) | 126 (13) | 129 (13) | 125.7 (14.8) | 123.3 (13.4) | 124 (110–140) | 125 (117–140) |
| Diastolic | 77 (8.8) | 75.1 (10.7) | 77 (8) | 76 (10) | 74.7 (10.1) | 76.5 (9.8) | 77 (68–82) | 76 (70–81) |
| Serum creatinine, mg/dL | 1.0 (0.28) | 1.0 (0.3) | 1.02 (0.27) | 0.96 (0.27) | 1.3 (0.4) | 1.3 (0.4) | 1.11 (0.83–1.39) | 1.03 (0.84–1.38) |
| eGFR, mL/min/1.73 m2a | 80.5 (21.6) | 79.1 (25.5) | 83 (24) | 86 (25) | 84.9 (29.8) | 87.4 (34.4) | 66.7 (55.4–82.5) | 72.7 (58.1–88.6) |
| Serum albumin, g/dL | 2.6 (2–2.9) | 2.6 (2.3–2.9) | 2.4 (1.8–2.7) | 2.5 (1.9–2.7) | 2.5 (2.1–2.9) | 2.5 (2.1–2.9) | 2.2 (1.8–2.5) | 2.2 (2.0–2.6) |
| Serum cholesterol, mg/dL | 263.8 (70.2) | 264.1 (57.8) | 273 (77) | 283 (96) | 145.1 (61.6) | 144.8 (69.8) | 274.1 (212.4–335.9) | 289.6 (239.4–366.8) |
| Urinary protein, g/24 hb | 7.4 (6.7–11.6) | 7.4 (4.8–11.3) | 6.1 (4–10.1) | 6.2 (5.1–9.3) | 8.9 (6.8–12.3) | 8.9 (6.7–12.9) | 7.7 (4.6–10.4) | 7.2 (5.4–8.9) |
| Anti-PLA2R positive, n (%) | 24/32 (75) | 29/37 (78) | 22/30 (73) | 19/32 (59) | 50/65 (77) | 46/65 (71) | 27/37 (73) | 28/38 (73.7) |
| Anti-PLA2R level, RU/mL | 113 (61–151) | 59 (37–150) | 58 (40–81) | 63 (52–87) | 409 (163–834) | 413 (206–961) | 40.5 (0–275.5) | 43.3 (0–457.5) |
| Use of RAS inhibitors, n (%) | 43/43 (100) | 39/43 (91) | NA | NA | 37/37 (100) | 36/38 (94.7) | ||
Data shown as n (%), mean (SD), or median (IQR). GEMRITUX provides IQR including all anti-PLA2R values while other trials appear to provide IQR for just the anti-PLA2R +
CsA cyclosporine A, eGFR estimated glomerular filtration rate, GC-CYC glucocorticoids-cyclophosphamide, IQR interquartile range, NA data not available, NIAT non-immunosuppressive antiproteinuric treatment, PLA2R phospholipase A2 receptor, RAS renin-angiotensin system, RTX rituximab, SD standard deviation, TAC-RTX tacrolimus-rituximab
aeGFR was calculated using CKD-EPI in STARMEN and RI-CYCLO and using MDRD-4 in GEMRITUX. In MENTOR, measured creatinine clearance data are presented in the table, and we estimated GFR using CKD-EPI at 58.4 mL/min/1.73 m2 for rituximab, and 59.8 mL/min/1.73 m2 for cyclosporine arms, respectively
bExcept in GEMRITUX, proteinuria was determined as grams per 24 h. In GEMRITUX, proteinuria was measured as urinary protein-to-creatinine ratio (showed as g/g)