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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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
Are there results?: Not yet: the study is under way

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

Show all 11Show fewer

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.

City, postcode or hospital

Sites recruiting now only

8 sites in 1 country

France8 sites, 8 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
Recruiting

Other trials in France

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.

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 groups in NCT06350630
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.

26 Jun 202531 Dec 2030

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.
More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
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)

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

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

All IgA Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA)Nephropathy Course QUIgAN Study
ClinicalTrials.gov ID: NCT06350630
Acronym / sponsor ID: QUIgAN / 20PH284
Conditions: IgA Nephropathy
Keywords: Hydroxychloroquine, proteinuria
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 334 participants (estimated)
Lead sponsor: Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
Collaborators: Ministry of Health, France
Study start: 26 Jun 2025 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 5 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: double blind trial randomized

Arm	Type	Receives
Hydroxychloroquine	Experimental	Drug: Hydroxychloroquine Oral TabletActive hydroxychloroquine once daily by oral route at 6.5 mg/kg of ideal weight/day, with maximal dose of 400/mg day
Placebo	Placebo comparator	Drug: Placebo oral tablet

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydroxychloroquine Oral TabletActive hydroxychloroquine once daily by oral route at 6.5 mg/kg of ideal weight/day, with maximal dose of 400mg/day for 3 years	Drug	Hydroxychloroquine
Placebo oral tabletplacebo once daily by oral route (no active drug - same dosage as hydroxychloroquine )	Drug	Placebo

Primary outcome

Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution
Time frame: 3 years

17 secondary outcomes

nephrological follow-up: proteinuria
Time frame: 1 year
nephrological follow-up: albuminuria
Time frame: 1 year
nephrological follow-up: GFR
Time frame: 1 year
nephrological follow-up: hematuria
Time frame: 1 year
nephrological follow-up: systolic and diastolic blood pressure
Time frame: 1 year
nephrological follow-up: proteinuria
Time frame: 2 years
nephrological follow-up: albuminuria
Time frame: 2 years
nephrological follow-up: GFR
Time frame: 2 years
nephrological follow-up: hematuria
Time frame: 2 years
nephrological follow-up: systolic and diastolic blood pressure
Time frame: 2 years
nephrological follow-up: proteinuria
Time frame: 3 years
nephrological follow-up: albuminuria
Time frame: 3 years
nephrological follow-up: hematuria
Time frame: 3 years
nephrological follow-up: systolic and diastolic blood pressure
Time frame: 3 years
end stage renal disease (GFR< 15mL/min/1.73m²)
Time frame: 3 years
death
Time frame: 3 years
adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia)
Time frame: 3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.

Related trials for IgA Nephropathy

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

CHU Gabriel Montpied

Clermont-Ferrand, France

0473751425 ext. +33

aheng@chu-clermontferrand.fr

Hospices Civils de Lyon

Lyon, France

0472110260 ext. +33

fitsum.guebre-egziabher@chu-lyon.fr

AP-HM Hôpital de la Conception

Marseille, France

0662426166 ext. +33

thomas.robert@ap-hm.fr

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06350630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.