IgA NephropathyPhase 2QUIgANNCT06350630
Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study
A Phase 2 study testing Hydroxychloroquine Oral Tablet in people with IgA Nephropathy, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Hydroxychloroquine Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 8 sitesFrance
- Study dates
- 26 Jun 2025to 31 Dec 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHU Gabriel Montpied
Clermont-Ferrand, 63000
Anne-Elisabeth HENG, MD, 0473751425 ext. +33, aheng@chu-clermontferrand.fr
- Recruiting
Hospices Civils de Lyon
Lyon, 69437
Fitsum GUEBRE-EGZIABHER, MD, 0472110260 ext. +33, fitsum.guebre-egziabher@chu-lyon.fr
- Recruiting
AP-HM Hôpital de la Conception
Marseille, 13385
Thomas ROBERT, MD, 0662426166 ext. +33, thomas.robert@ap-hm.fr
- Recruiting
Chr Metz Thionville Hopital Mercy
Metz, 57530
MATHIS MICHEL, MD, (0)387553131 ext. +33, mathis.michel@chr-metz-thionville.fr
- Recruiting
APHP Hôpital Bichat
Paris, 75018
Eric DAUGAS, PU-PH, 0140257101 ext. +33, eric.daugas@aphp.fr
- Recruiting
APHP Hôpital de Tenon
Paris, 75020
Khalil EL KAROUI, PU-PH, 0156016317 ext. +33, khalil.el-karoui@aphp.fr
- Recruiting
CHU Lyon Sud
Pierre-Bénite, 69495
Sarah MEZAACHE, MD, 0478863712 ext. +33, sarah.mezaache@chu-lyon.fr
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Nicolas MAILLARD, MD, 0477828127 ext. +33, nicolas.maillard@chu-st-etienne.fr
Carine LABRUYERE, 0477120469 ext. +33, carine.labruyere@chu-st-etienne.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- IgA Nephropathy
- Being tested
- Hydroxychloroquine Oral Tablet, Placebo oral tablet
- Keywords
- Hydroxychloroquine, proteinuria
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Oral TabletDrug
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 tabletDrug
placebo once daily by oral route (no active drug - same dosage as hydroxychloroquine )
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Active hydroxychloroquine once daily by oral route at 6.5 mg/kg of ideal weight/day, with maximal dose of 400/mg day Receives: Drug: Hydroxychloroquine Oral Tablet |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution
Measured: 3 years
Secondary outcomes (17)
nephrological follow-up: proteinuria
Measured: 1 year
nephrological follow-up: albuminuria
Measured: 1 year
nephrological follow-up: GFR
Measured: 1 year
nephrological follow-up: hematuria
Measured: 1 year
nephrological follow-up: systolic and diastolic blood pressure
Measured: 1 year
nephrological follow-up: proteinuria
Measured: 2 years
nephrological follow-up: albuminuria
Measured: 2 years
nephrological follow-up: GFR
Measured: 2 years
nephrological follow-up: hematuria
Measured: 2 years
nephrological follow-up: systolic and diastolic blood pressure
Measured: 2 years
nephrological follow-up: proteinuria
Measured: 3 years
nephrological follow-up: albuminuria
Measured: 3 years
nephrological follow-up: hematuria
Measured: 3 years
nephrological follow-up: systolic and diastolic blood pressure
Measured: 3 years
end stage renal disease (GFR< 15mL/min/1.73m²)
Measured: 3 years
death
Measured: 3 years
adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start26 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind trial randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350630
- Sponsor's protocol ID
- 20PH284
- Other IDs
- 2024-512653-25-00
- Acronym
- QUIgAN
- Status last verified
- Oct 2026
- First submitted
- 28 Mar 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No