{ "data": { "asOf": "2026-10-30T22:27:22.831Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06350630", "title": "Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study", "scientificTitle": "Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA)Nephropathy Course QUIgAN Study", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "IgA Nephropathy" ], "interventions": [ { "name": "Hydroxychloroquine Oral Tablet", "type": "DRUG", "description": "Active hydroxychloroquine once daily by oral route at 6.5 mg/kg of ideal weight/day, with maximal dose of 400mg/day for 3 years" }, { "name": "Placebo oral tablet", "type": "DRUG", "description": "placebo once daily by oral route (no active drug - same dosage as hydroxychloroquine )" } ], "sponsor": { "name": "Centre Hospitalier Universitaire de Saint Etienne", "type": "OTHER" }, "locations": [ { "city": "Clermont-Ferrand", "country": "France", "facility": "CHU Gabriel Montpied" }, { "city": "Lyon", "country": "France", "facility": "Hospices Civils de Lyon" }, { "city": "Marseille", "country": "France", "facility": "AP-HM Hôpital de la Conception" }, { "city": "Metz", "country": "France", "facility": "Chr Metz Thionville Hopital Mercy" }, { "city": "Paris", "country": "France", "facility": "APHP Hôpital Bichat" }, { "city": "Paris", "country": "France", "facility": "APHP Hôpital de Tenon" }, { "city": "Pierre-Bénite", "country": "France", "facility": "CHU Lyon Sud" }, { "city": "Saint-Etienne", "country": "France", "facility": "CHU de Saint-Etienne" } ], "outcomes": { "other": [], "primary": [ "Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution" ], "secondary": [ "nephrological follow-up: proteinuria", "nephrological follow-up: albuminuria", "nephrological follow-up: GFR", "nephrological follow-up: hematuria", "nephrological follow-up: systolic and diastolic blood pressure", "nephrological follow-up: proteinuria", "nephrological follow-up: albuminuria", "nephrological follow-up: GFR", "nephrological follow-up: hematuria", "nephrological follow-up: systolic and diastolic blood pressure", "nephrological follow-up: proteinuria", "nephrological follow-up: albuminuria", "nephrological follow-up: hematuria", "nephrological follow-up: systolic and diastolic blood pressure", "end stage renal disease (GFR< 15mL/min/1.73m²)", "death", "adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Social security affiliation\n* Signed informed consent\n* With biopsy proven IgA nephropathy (any vintage)\n* With at least one Oxford lesion (M, E, S, T, C) on last available kidney biopsy - With urine albumin/creatinine \\> 300mg/g,\n* under maximal tolerated labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors for at least 3 months\n* Sodium-Glucose Transport Protein 2 (SGLT-2) inhibitors initiated at least 1 month before inclusion visit\n* Only patients treated with SGLT2i and RAAS dual therapy before inclusion\n* With estimate GFR above 15 mL/min/1,73m² (Chronic Kidney Disease - EPIdemiology collaboration CKD-EPI formula)\n* Woman in childbearing with a highly effective method of contraception\n* Agreement of woman in childbearing potential (WOCBP) to perform a urine pregnancy test every month until three months after the end of study treatment\n* 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.\n\nExclusion Criteria:\n\n* Secondary IgA nephropathy (Henoch Schonlein purpura, cirrhosis, inflammatory bowel disease)\n* Corticosteroid or immunosuppressive therapies in the past year before screening\n* Contra-indication to hydroxychloroquine (retinopathy, maculopathy, history of intolerance to hydroxychloroquine…)\n* Uncontrolled hypertension (systolic blood pression\\> 160 mmHg and/or diastolic blood pression \\>110 mmHg )\n* Long QT interval and/or QT prolonging medicines\n* Pregnancy or lactation", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 334 }, "startDate": "2025-06-26", "completionDate": "2030-12-31", "lastUpdated": "2026-10-09T00:00:00.000Z", "firstPosted": "2024-04-05T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT06350630" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT06350630", "declaredBy": "clinicaltrials_gov" }, { "idType": "euct", "idValue": "2024-512653-25-00", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06350630", "sourceUrl": "https://clinicaltrials.gov/study/NCT06350630", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:33:03.752Z", "payloadSha256": "682a089a8c2c745c58cd9c56730a565fc72f6af13e8fc7ca5ea39e33dd65a233", "piiRedacted": true } ], "citation": { "canonicalId": "NCT06350630", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06350630", "verifyAt": "https://clinicaltrials.gov/study/NCT06350630", "retrievedAt": "2026-10-28T04:33:03.752Z", "payloadSha256": "682a089a8c2c745c58cd9c56730a565fc72f6af13e8fc7ca5ea39e33dd65a233", "text": "ClinicalTrials.gov, record NCT06350630 (https://clinicaltrials.gov/study/NCT06350630), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT06350630, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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