protocolSection identificationModule nctId: NCT06350630, orgStudyIdInfo id: 20PH284, secondaryIdInfos id: 2024-512653-25-00, type: CTIS, briefTitle: Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study, acronym: QUIgAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, collaborators name: Ministry of Health, France, descriptionModule briefSummary: 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 Erythematosus) and very low priced.One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group).Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study., conditionsModule conditions: IgA Nephropathy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double blind trial randomized, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 334, type: ESTIMATED, armsInterventionsModule interventions name: Hydroxychloroquine Oral Tablet, interventions name: Placebo oral tablet, outcomesModule primaryOutcomes measure: Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution, secondaryOutcomes measure: nephrological follow-up: proteinuria, secondaryOutcomes measure: nephrological follow-up: albuminuria, secondaryOutcomes measure: nephrological follow-up: GFR, secondaryOutcomes measure: nephrological follow-up: hematuria, secondaryOutcomes measure: nephrological follow-up: systolic and diastolic blood pressure, secondaryOutcomes measure: nephrological follow-up: proteinuria, secondaryOutcomes measure: nephrological follow-up: albuminuria, secondaryOutcomes measure: nephrological follow-up: GFR, secondaryOutcomes measure: nephrological follow-up: hematuria, secondaryOutcomes measure: nephrological follow-up: systolic and diastolic blood pressure, secondaryOutcomes measure: nephrological follow-up: proteinuria, secondaryOutcomes measure: nephrological follow-up: albuminuria, secondaryOutcomes measure: nephrological follow-up: hematuria, secondaryOutcomes measure: nephrological follow-up: systolic and diastolic blood pressure, secondaryOutcomes measure: end stage renal disease (GFR< 15mL/min/1.73m²), secondaryOutcomes measure: death, secondaryOutcomes measure: adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Gabriel Montpied, city: Clermont-Ferrand, zip: 63000, country: France, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Hospices Civils de Lyon, city: Lyon, zip: 69437, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: AP-HM Hôpital de la Conception, city: Marseille, zip: 13385, country: France, contacts name: Thomas ROBERT, MD, role: CONTACT, phone: 0662426166, phoneExt: +33, email: thomas.robert@ap-hm.fr, geoPoint lat: 43.29551, lon: 5.38958, locations facility: APHP Hôpital Bichat, city: Paris, zip: 75018, country: France, contacts name: Eric DAUGAS, PU-PH, role: CONTACT, phone: 0140257101, phoneExt: +33, email: eric.daugas@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: APHP Hôpital de Tenon, city: Paris, zip: 75020, country: France, contacts name: Khalil EL KAROUI, PU-PH, role: CONTACT, phone: 0156016317, phoneExt: +33, email: khalil.el-karoui@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Lyon Sud, city: Pierre-Bénite, zip: 69495, country: France, contacts name: Sarah MEZAACHE, MD, role: CONTACT, phone: 0478863712, phoneExt: +33, email: sarah.mezaache@chu-lyon.fr, geoPoint lat: 45.7009, lon: 4.82511, locations facility: CHU de Saint-Etienne, city: Saint-Étienne, zip: 42055, country: France, contacts name: Nicolas MAILLARD, MD, role: CONTACT, phone: 0477828127, phoneExt: +33, email: nicolas.maillard@chu-st-etienne.fr, contacts name: Carine LABRUYERE, role: CONTACT, phone: 0477120469, phoneExt: +33, email: carine.labruyere@chu-st-etienne.fr, geoPoint lat: 45.43389, lon: 4.39, hasResults: False