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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)
  1. aISN/RPS International Society of Nephrology/Renal Pathology Society.
  2. bComplete remission was defined as having a) less than 0.3 g/day proteinuria, b) normal urine sediment, c) normal serum albumin concentration and d) creatinine value less than 15% above baseline. Partial remission was defined as having a) 0.3 to 2.9 g/day proteinuria, b) serum albumin at least 30 g/L and c) stable renal function.
  3. cSLEDAI, Systemic Lupus Erythematosus Activity Index.
  4. dSLICC/ACR, Systemic Lupus International Collaborative Clinics/American College of Rheumatology.