Table 2 Participant characteristics at randomization
From: The Steroids In the Maintenance of remission of Proliferative Lupus nephritis (SIMPL) pilot trial
Overall | Prednisone continuation | Prednisone withdrawal | |
|---|---|---|---|
(n=15) | (n=8) | (n=7) | |
Age (yr), mean (sd) | 34.2 (11.2) | 39.2 (12.8) | 28.4 (5.6) |
Female gender, n (%) | 13 (86.7) | 6 (75) | 7 (100) |
On steroids >12 months, n (%) | 10 (77) | 7 (88) | 3 (60) |
Duration from biopsy to enrollment (days), median (25th to 75th percentile) | 342 (463) | 495 (497) | 331 (548) |
Serum creatinine (umol/L), mean (sd) | 82.9 (45.4) | 85.9 (34.5) | 79.4 (58.4) |
Proteinuria (g/mmol), mean (sd) | 0.07 (0.07) | 0.06 (0.07) | 0.09 (0.07) |
Hemoglobin A1c (%), mean (sd) | 5.08 (0.62) | 4.8 (0.87) | 5.3 (0.2) |
Blood Pressure, mmHg (sd) | |||
Systolic | 118.3 (16.3) | 125.5 (18.1) | 110 (9.4) |
Diastolic | 73.1 (10.4) | 76.3 (10.7) | 69.4 (9.5) |
Renal Biopsy Class, n (%)a | |||
III | 4 (29) | 3 (43) | 1 (14) |
IV | 10 (71) | 4 (57) | 6 (86) |
V | 8 (57) | 3 (43) | 5 (71) |
Complete remissionb, n (%) | 9 (60) | 7 (88) | 2 (29) |
SLEDAI total scorec, mean (sd) | 1.3 (2.9) | 0.25 (0.7) | 2.57 (3.9) |
SLICC/ACR indexd, mean (sd) | 0.5 (0.9) | 0.75 (1.2) | 0.29 (0.5) |
Prednisone dose (mg/day), mean (sd) | 8.1 (1.9) | 8.8 (1.6) | 7.5 (2.04) |
Baseline Cytotoxic Use | |||
Cyclophosphamide, n (%) | 0 | 0 | 0 |
Mycophenolate, n (%) | 9 (60) | 4 (50) | 5 (71) |
Azathioprine, n (%) | 4 (27) | 3 (38) | 1 (14) |
None, n (%) | 2 (13) | 1 (12.5) | 1 (14) |