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Table 1 Definition of response criteria

From: Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study

   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   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
  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
  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
  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
  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
  1. Baseline was defined as proteinuria or renal function (serum creatinine and EGFR) before the current flare of LN. According to these entry parameters, each patient was attributed to group 3A, 3B or 3C and 4A, 4B or 4C, respectively. Next, the maximal proteinuria or maximal serum creatinine/minimal EGFR during the current LN flare was determined. Based on these numbers, the additional urinary protein excretion (maximal amount of proteinura - baseline proteinuria) and/or impairment of renal function (maximal creatinine - baseline creatinine; baseline EGFR - minimum EGFR) could be defined for each patient individually. Response to DSG at the end of cycle 4, 6 or 9 was then defined in relation to the patient's individual entry parameters according to the criteria in Table 1.
  2. DSG, deoxyspergualin; EGFR, estimated glomerular filtration rate; SD, stable disease; TF, treatment failure.
  3. 1 additional urinary protein excretion: maximal amount of proteinuria (g/day) - baseline proteinuria