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Early start corticosteroids versus standard care (RASBs followed by corticosteroids) for proteinuria in Immunoglobulin A Nephropathy (IgAN) patients with active renal lesions identified by kidney biopsy and RASBs combined with corticosteroids versus sodium-glucose cotransporter2 inhibitor combined with RASBs for proteinuria and renal function in IgAN patients with chronic renal lesions identified by kidney biopsy. A PROJECT FOR TWO MULTICENTRE, PROSPECTIVE OPEN LABEL RANDOMIZED CLINICAL STUDIES TO EVALUATE THE EFFECT OF TARGETED THERAPY BASED ON KIDNEY BIOPSY FINDINGS IN IgAN PATIENTS (CLIgAN)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517861-18-00
Enrollment
432
Registered
2024-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic IgA nephropathy (IgAN)

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

DRUGPREDNISONE
DRUGDAPAGLIFLOZIN
DRUGRAMIPRIL
DRUGLOSARTAN

Sponsors

Fondazione Schena Centro Europeo Della Ricerca Sulle Malattie Renali
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026