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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Apr 3, 2024

Keywords

ClinConnect Summary

The QUIgAN study is a clinical trial that is investigating the effects of a medication called hydroxychloroquine on a kidney condition known as IgA nephropathy, or Berger disease. This condition can lead to serious kidney problems and affects many people worldwide. The researchers want to see if hydroxychloroquine, which is already used for other health issues like lupus and is known to be safe, can help reduce protein levels in urine, indicating better kidney function. Previous research from China showed promising results, and this study aims to confirm those findings in a larger group of people in France over a longer period.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of IgA nephropathy. They should have specific kidney function results and must be on certain medications for at least three months. Women of childbearing age will need to use birth control during the study. Participants will be randomly assigned to receive either hydroxychloroquine or a placebo (a treatment that has no active ingredients) and will be monitored closely for any changes in their kidney health. This study is not yet recruiting, but it aims to provide valuable information to improve treatment for those with IgA nephropathy.

Gender

ALL

Eligibility criteria

• 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