Phase 2Recruiting

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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Academic or other)
Enrolment
334 planned
Conditions
IgA Nephropathy
Interventions
Hydroxychloroquine Oral Tablet; Placebo oral tablet
Ages
adults, older adults
Registry
NCT06350630, CTIS2024-512653-25-00

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

  • Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered