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Therapeutic effect of Hydroxychloroquine on IgA Nephropathy course - QUIgAN Study
EU CTIS ID: 2024-512653-25-00
What this study is testing
To demonstrate, at 3 years, the efficacy of Hydroxychloroquine versus placebo to improve GFR decrease in biopsy-proven IgA nephropathy patients in patients with albuminuria > 300mg/g despite an optimized nephroprotective treatment with RAAS inhibitors, and with at least one Oxford lesion
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Social security affiliation
- Only patients treated with dual SGLT2i and RAAS therapy before inclusion
- Signed informed consent
- Patients over 18 years-old and < 75 years
- With biopsy proven IgA nephropathy (any vintage)
- With urine albumin/creatinine > 300mg/g
You likely can't join if
- Secondary IgA nephropathy (Henoch Schonlein purpura, cirrhosis, inflammatory bowel disease)
- Corticosteroid (systemic and/or targeted-release formulation) or immunosuppressive therapies in the past year before screening
- Contra-indication to hydroxychloroquine (retinopathy, maculopathy, history of intolerance to HCQ…)
- Uncontrolled hypertension (SBP> 160 and/or DBP>110)
- Long QT interval and/or QT prolonging medicines
- Pregnancy or lactation
See the full eligibility criteria
- Social security affiliation
- Only patients treated with dual SGLT2i and RAAS therapy before inclusion
- Signed informed consent
- Patients over 18 years-old and < 75 years
- With biopsy proven IgA nephropathy (any vintage)
- With urine albumin/creatinine > 300mg/g
- Under maximal tolerated labeled dose of RAAS inhibitors for at least 3 months
- With at least one Oxford lesion (M, E, S, T, C) on last available kidney biopsy
- With eGFR above 15 mL/min/1,73m² (CKD-EPI formula)
- With at least one highly effective contraceptive method for women of childbearing age
- Secondary IgA nephropathy (Henoch Schonlein purpura, cirrhosis, inflammatory bowel disease)
- Corticosteroid (systemic and/or targeted-release formulation) or immunosuppressive therapies in the past year before screening
- Contra-indication to hydroxychloroquine (retinopathy, maculopathy, history of intolerance to HCQ…)
- Uncontrolled hypertension (SBP> 160 and/or DBP>110)
- Long QT interval and/or QT prolonging medicines
- Pregnancy or lactation
- - QT prolonging medicines : citalopram, escitalopram, hydroxyzine, dompéridone and pipéraquine
- Sparsentan initiated less than 1 month before inclusion visit
- Abnormal findings in at least one ophthalmological examination performed at inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.