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NCT Number: NCT06350630

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

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.

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Gabriel Montpied, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine Oral Tablet

Drug

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

Placebo oral tablet

Drug

placebo once daily by oral route (no active drug - same dosage as hydroxychloroquine )

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. nephrological follow-up: proteinuria

    Time frame: 1 year

  2. nephrological follow-up: albuminuria

    Time frame: 1 year

  3. nephrological follow-up: GFR

    Time frame: 1 year

  4. nephrological follow-up: hematuria

    Time frame: 1 year

  5. nephrological follow-up: systolic and diastolic blood pressure

    Time frame: 1 year

  6. nephrological follow-up: proteinuria

    Time frame: 2 years

  7. nephrological follow-up: albuminuria

    Time frame: 2 years

  8. nephrological follow-up: GFR

    Time frame: 2 years

  9. nephrological follow-up: hematuria

    Time frame: 2 years

  10. nephrological follow-up: systolic and diastolic blood pressure

    Time frame: 2 years

  11. nephrological follow-up: proteinuria

    Time frame: 3 years

  12. nephrological follow-up: albuminuria

    Time frame: 3 years

  13. nephrological follow-up: hematuria

    Time frame: 3 years

  14. nephrological follow-up: systolic and diastolic blood pressure

    Time frame: 3 years

  15. end stage renal disease (GFR< 15mL/min/1.73m²)

    Time frame: 3 years

  16. death

    Time frame: 3 years

  17. adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia)

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: QUIgAN

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Apr 5, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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