Idiopathic IgA nephropathy (IgAN)
Conditions
Brief summary
Between-arms difference in proteinuria reduction within 4 months and in nonresponders within 8 months in ACIgAN study., Between-arms difference in proteinuria reduction within 10 months in CHRONIgAN study.
Detailed description
eGFR slope calculated as mean of individual slope obtained from individual linear regression of eGFR overtime (3 years);, eGFR decline > 40 % from the baseline value;, composite end point: GFR decline > 40%, ESKD (defined as long-term GFR <= 15 ml/min/1.73m2 for more than three months or need for maintenance dialysis or kidney transplantation) or death due to kidney disease;, absolute difference between last GFR value and baseline GFR;, stable renal function defined as a decline in GFR <= 5 ml/min/1.73m2 at the end of three years follow- up, mean annual change in the slope of the reciprocal of serum creatinine concentration;, time-averaged proteinuria (TA-P) calculated as the weighted mean of all postrandomisation measurement, with weights representing the time elapsed since the previous measurement;, proteinuria slope, calculated as a mean of individual slope, obtained from individual linear regression of daily proteinuria overtime (3 years);, complete remission of proteinuria defined as achievement of urinary protein level <= 0.2 g/day or a urinary protein-to-creatinine ratio <= 0.2 g/g;, partial remission of proteinuria defined as achievement of a urinary protein reduction >= 50% or greater compared with the baseline value.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-arms difference in proteinuria reduction within 4 months and in nonresponders within 8 months in ACIgAN study., Between-arms difference in proteinuria reduction within 10 months in CHRONIgAN study. | — |
Secondary
| Measure | Time frame |
|---|---|
| eGFR slope calculated as mean of individual slope obtained from individual linear regression of eGFR overtime (3 years);, eGFR decline > 40 % from the baseline value;, composite end point: GFR decline > 40%, ESKD (defined as long-term GFR <= 15 ml/min/1.73m2 for more than three months or need for maintenance dialysis or kidney transplantation) or death due to kidney disease;, absolute difference between last GFR value and baseline GFR;, stable renal function defined as a decline in GFR <= 5 ml/min/1.73m2 at the end of three years follow- up, mean annual change in the slope of the reciprocal of serum creatinine concentration;, time-averaged proteinuria (TA-P) calculated as the weighted mean of all postrandomisation measurement, with weights representing the time elapsed since the previous measurement;, proteinuria slope, calculated as a mean of individual slope, obtained from individual linear regression of daily proteinuria overtime (3 years);, complete remission of proteinuria defined | — |
Countries
Italy