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Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study

RecruitingPhase 2Ages 18 Years - anyAllCentre Hospitalier Universitaire de Saint Etienne
NCT06350630 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity. In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus E

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📋 Eligibility rules (as published)
Inclusion Criteria: * Social security affiliation * Signed informed consent * With biopsy proven IgA nephropathy (any vintage) * With at least one Oxford lesion (M, E, S, T, C) on last available kidney biopsy - With urine albumin/creatinine \> 300mg/g, * under maximal tolerated labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors for at least 3 months * Sodium-Glucose Transport Protein 2 (SGLT-2) inhibitors initiated at least 1 month before inclusion visit * Only patients treated with SGLT2i and RAAS dual therapy before inclusion * With estimate GFR above 15 mL/min/1,73m² (Chronic Kidney Disease - EPIdemiology collaboration CKD-EPI formula) * Woman in childbearing with a highly effective method of contraception * Agreement of woman in childbearing potential (WOCBP) to perform a urine pregnancy test every month until three months after the end of study treatment * Agreement of fertile male with WOCBP partner to use a condom for the duration of the study treatment up to 3 months after treatment the end of study treatment. Exclusion Criteria: * Secondary IgA nephropathy (Henoch Schonlein purpura, cirrhosis, inflammatory bowel disease) * Corticosteroid or immunosuppressive therapies in the past year before screening * Contra-indication to hydroxychloroquine (retinopathy, maculopathy, history of intolerance to hydroxychloroquine…) * Uncontrolled hypertension (systolic blood pression\> 160 mmHg and/or diastolic blood pression \>110 mmHg ) * Long QT interval and/or QT prolonging medicines * Pregnancy or lactation
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What it tests

  • Hydroxychloroquine Oral Tablet
  • Placebo oral tablet
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Where

8 sites
CHU Gabriel Montpied
Clermont-Ferrand, France
Hospices Civils de Lyon
Lyon, France
AP-HM Hôpital de la Conception
Marseille, France
Chr Metz Thionville Hopital Mercy
Metz, France
APHP Hôpital Bichat
Paris, France
APHP Hôpital de Tenon
Paris, France
CHU Lyon Sud
Pierre-Bénite, France
CHU de Saint-Etienne
Saint-Etienne, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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