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New treatment option for IgA Nephropathy
Official title Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study
ClinicalTrials.gov ID: NCT06350630
What this study is testing
What is Hydroxychloroquine Oral Tablet?
Hydroxychloroquine Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for iga nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Lyon, France
- Marseille, France
- Paris, France
- Pierre-Bénite, France
- Saint-Etienne, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Lyon, France; Marseille, France; Paris, France; Pierre-Bénite, France; Saint-Etienne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.