Table 2.
Secondary end points on the basis of the available patients at the end of the trial phase: high-GFR arm
End Point | Supportive Care, n=54 | Corticosteroid Monotherapy, n=55 | P Value | ||
---|---|---|---|---|---|
Patients with Available Data, No. | End Point Value, Mean±SD or No. (%) | Patients with Available Data, No. | End Point Value, Mean±SD or No. (%) | ||
GFR decrease ≥30 ml/min per 1.73 m2 | 52 | 6 (12) | 53 | 5 (9) | 0.68 |
Onset of ESRD | 52 | 5 (10) | 53 | 1 (2) | 0.16 |
Disappearance of microhematuria | 38a | 7 (18) | 40a | 19 (48) | 0.02 |
Absolute GFR changes at month 36, ml/min per 1.73 m2 | 48 | −3.78±13.41 | 52 | −4.07±15.66 | 0.98 |
Mean annual change in the slope of the reciprocal of serum creatinine concentration, mg/dl | 53 | −0.02±0.06 | 52 | −0.01±0.06 | 0.35 |
Urinary protein-to-creatinine ratio at month 12, g/g | 47 | 0.79±0.74 | 41 | 0.5±0.52 | 0.01 |
Urinary protein-to-creatinine ratio at month 36, g/g | 46 | 0.80±0.64 | 43 | 0.57±0.53 | 0.26 |
A total of 45 patients in the supportive care group and 50 patients in the corticosteroid monotherapy group had microhematuria at baseline.