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

Study acronym: QUIgAN
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 7 to 8 Eligibility criteria expanded, about 17 words · Secondary endpoints: details revised at 1 of 17 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 17 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2025 to Jun 26, 2025 · Site details revised at 7 of 7 sitesv11 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2025 to Jun 26, 2025
    • Site details revised at 7 of 7 sites
  3. Notable Start date: Apr 2025 to Jun 2025 Eligibility criteria expanded, about 78 wordsv10 Show 1 more changeShow less
    • Eligibility criteria expanded, about 78 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Start date: Mar 2025 to Apr 2025v9
  5. Minor Start date: Feb 2025 to Mar 2025v8
Show 6 earlier versionsHide 6 earlier versions
  1. Notable Start date: Dec 2024 to Feb 2025v7
  2. Minor Start date: Nov 2024 to Dec 2024v6
  3. Minor Start date: Oct 2024 to Nov 2024v5
  4. Minor Start date: Sep 2024 to Oct 2024v4
  5. Notable Start date: Jun 2024 to Sep 2024v3
  6. Notable Start date: May 1, 2024 to Jun 2024v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06350630
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Ministry of Health, France
Conditions IgA Nephropathy
Enrollment 334 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov