Table 2.

Observed change from baseline in SCr, first-morning UPCR, and eGFR

VariablePlaceboTGF-β1 mAb
2 mg10 mg50 mg
SCr, mg/dl
 Baseline
  N103105103105
  Mean±SD2.21±0.592.13±0.582.09±0.652.13±0.63
 6 months
  n89919287
  Mean±SD2.44±0.862.38±0.712.36±0.942.46±1.02
  Change from baseline0.23±0.560.28±0.400.25±0.460.33±0.60
 End point
  n85909182
  Mean±SD2.49±0.972.50±0.832.54±1.192.47±0.94
  Change from baseline0.33±0.670.41±0.470.47±0.760.41±0.58
First-morning UPCR, g/g
 Baseline
  N103105103105
  Mean±SD3.12±2.523.27±2.573.30±2.453.35±2.55
 6 months
  n88929490
  Mean±SD3.03±2.773.93±6.903.21±2.543.48±3.56
  Change from baseline0.08±1.470.66±6.24−0.06±1.650.13±2.16
 End point
  n82878581
  Mean±SD3.21±2.753.50±2.713.64±3.263.45±3.42
  Change from baseline0.41±1.760.31±2.530.47±2.320.26±2.28
eGFR, ml/min per 1.73 m2
 Baseline
  N103105103105
  Mean±SD33.84±11.0635.71±11.7236.36±12.5235.95±12.09
 6 months
  n89919287
  Mean±SD31.25±11.4831.67±11.3832.99±13.0932.49±13.19
  Change from baseline−2.51±5.74−4.23±5.92−3.06±5.54−3.90±5.78
 End point
  n85909182
  Mean±SD31.23±12.1630.94±12.9131.28±13.5232.34±13.80
  Change from baseline−3.39±5.47−5.38±6.27−5.38±7.55−4.71±8.84
  • Data are means±SD. Baseline SCr is the mean of the last two available values obtained on or before the first date of administration of investigational drug. End point SCr value is the mean of two scheduled values at the end of treatment. Baseline UPCR is the mean of the available values at the last visit obtained on or before the first date of administration of investigational drug. The mean values at each visit were used in the analysis. Baseline eGFR is the average of the last two available values obtained on or before the first date of administration of investigational drug. End point eGFR value is the mean of two scheduled values at the end of treatment.