HYDROXYCHLOROQUINE SULFATE for IgA nephropathy

Inclusion criteria

• {"criterion_text":"- Social security affiliation\n- Only patients treated with dual SGLT2i and RAAS therapy before inclusion\n- Signed informed consent\n- Patients over 18 years-old\n- With biopsy proven IgA nephropathy (any vintage)\n- With urine albumin/creatinine > 300mg/g\n- Under maximal tolerated labeled dose of RAAS inhibitors for at least 3 months\n- With at least one Oxford lesion (M, E, S, T, C) on last available kidney biopsy\n- With eGFR above 15 mL/min/1,73m² (CKD-EPI formula)\n- With at least one highly effective contraceptive method for women of childbearing age"}

Exclusion criteria

• {"criterion_text":"- Secondary IgA nephropathy (Henoch Schonlein purpura, cirrhosis, inflammatory bowel disease)\n- Corticosteroid (systemic and/or targeted-release formulation) or immunosuppressive therapies in the past year before screening\n- Contra-indication to hydroxychloroquine (retinopathy, maculopathy, history of intolerance to HCQ…)\n- Uncontrolled hypertension (SBP> 160 and/or DBP>110)\n- Long QT interval and/or QT prolonging medicines\n- Pregnancy or lactation\n- \tQT prolonging medicines : citalopram, escitalopram, hydroxyzine, dompéridone and pipéraquine\n- Sparsentan initiated less than 1 month before inclusion visit"}

Primary endpoints

• {"endpoint_text":"- GFR slope form inclusion to 3 years","definition_or_measurement_approach":"Absolute difference of eGFR (CKD-EPI formula) between hydroxychloroquine and placebo groups over 3 years; primary measure described as GFR slope from inclusion to 3 years."}

Secondary endpoints

• {"endpoint_text":"- Difference between groups regarding routine nephrological clinical follow-up (proteinuria, albuminuria, GFR, hematuria, systolic and diastolic blood pressure) at 1, 2 and 3 years","definition_or_measurement_approach":"Comparison of routine nephrology measures (proteinuria, albuminuria, eGFR, hematuria, systolic and diastolic blood pressure) between groups at years 1, 2 and 3."}
• {"endpoint_text":"- Difference in proportion of end stage renal disease (GFR< 15mL/min/1.73m²) and deaths","definition_or_measurement_approach":"Proportion of participants progressing to end-stage renal disease (defined as eGFR < 15 mL/min/1.73 m²) and deaths compared between groups."}
• {"endpoint_text":"- Proportion of adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia)","definition_or_measurement_approach":"Proportion and types of adverse events and serious adverse events (including QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia) will be recorded and compared between groups."}
• {"endpoint_text":"- Correlations between hydroxychloroquine trough levels (mean trough level and maximum trough level) and evolution of proteinuria, eGFR, blood pressure","definition_or_measurement_approach":"Analysis of correlation between hydroxychloroquine trough concentrations (mean and maximum trough levels) and changes in proteinuria, eGFR and blood pressure."}
• {"endpoint_text":"- Correlations between hydroxychloroquine trough levels (mean trough level and maximum trough level) and adverse events (QT interval measurement, any adverse event, serious adverse events)","definition_or_measurement_approach":"Analysis of correlation between hydroxychloroquine trough concentrations (mean and maximum trough levels) and occurrence of adverse events, including QT interval measurements and serious adverse events."}
• {"endpoint_text":"- Biocollection of plasma, serum, urine and DNA samples","definition_or_measurement_approach":"Collection and storage of plasma, serum, urine and DNA samples for exploratory and future research (biocollection)."}

France

Earliest CTIS Part Ii Submission Date

22-08-2024

Latest Decision Or Authorization Date

08-08-2025

Processing Time Days

351

Number Of Sites

16

Number Of Participants

334

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Saint Etienne

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France