Table 1 Definition of response criteria
| Â | Â | Complete response | Partial response | Stable disease | Treatment failure |
|---|---|---|---|---|---|
Criteria | Baseline | Criteria 1 to 4 must be fulfilled | Criterion 1 must be fulfilled, and either 3 or 4, with the other not downgrading clinical response to SD or TF | Criterion 1 must be fulfilled, moreover 3 or 4, with the other not downgrading clinical response to TF | If one of criteria 1, 3 or 4 accounts |
1. prednisone equivalent) |  | < = 7.5 mg/day | < = 7.5 mg/day | < = 7.5 mg/day | ➢ 7.5 mg/day during cycle 4, 6 or 9 |
2. Urinary casts | Â | Not detectable | Detectable | Detectable | Detectable |
3. Proteinuria | A) Normal (< 0.15 g/day) | < 0.3 g/day | > 0.3 g, but a decrease of > = 25% of the maximum urinary protein excretion (measured at entry) achieved | decrease of <25% of the maximum urinary protein excretion (measured at entry) achieved during DSG treatment, no further increase of >25% in the maximum urinary protein excretion within the previous two cycles | Within the previous two cycles, a further increase of >25% in the maximum urinary protein excretion |
| Â | B) Elevated | Maximum increase over baseline of 25% | If >25% increased additional urinary protein excretion1 was decreased by at least 25% during DSG treatment | additional urinary protein excretion1 decreased by < 25% during DSG treatment; no further increase of >25% in the maximum urinary protein excretion within the previous two cycles | Within the previous two cycles, a further increase of >25% in the maximum urinary protein excretion |
| Â | C) In case of chronic nephrotic syndrome | Decrease in proteinuria of >50%, compared to the baseline | Decrease in proteinuria of at least 25%, but less than 50%, compared to the baseline | Decrease in proteinuria of <25%, maximal increase of 25%, compared to the baseline | Further increase in proteinuria of >25%, compared to the baseline |
4. Serum creatinine and EGFR | A) Both normal | Serum creatinine normal and impairment of EGFR2 improved by at least 75% | Serum creatinine normal and impairment of EGFR2 improved by at least 25%, but less than 75% | Serum creatinine remained elevated or impairment of EGFR2 improved by <25%, but did not further decrease by >25% within the previous two cycles | serum creatinine remained elevated, with a further increase of >20% over the maximum serum creatinine occurring within the previous two cycles or impairment of EGFR2 further increased by >25% within the last two cycles |
| Â | B) Decreased EGFR, normal serum creatinine | Serum creatinine normal and impairment of EGFR2 improved by >= 75% | Serum creatinine normal and impairment of EGFR2 improved by >= 25%, but <75% | impairment of EGFR2 improved by <25% or further decreased to <= 25% under the minimum EGFR within the last previous cycles | EGFR further decreased by >25% under the minimum EGFR within the previous two cycles |
| Â | C) Elevated serum creatinine | Maximum increase 20% | If >20% higher than baseline serum creatinine, at least a decrease from maximum creatinine during the trial of >15% | Serum creatinine concentration +/- 15% around the maximum value observed during the DSG trial | During the last two cycles, serum creatinine further increased by >15% over the maximum value observed during the DSG trial |