2024-512653-25-00招募中3 期
Therapeutic effect of Hydroxychloroquine on IgA Nephropathy course QUIgAN Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 334
- 试验地点
- 14
- 主要终点
- GFR slope form inclusion to 3 years
研究概览
简要总结
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
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Subject, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Social security affiliation
- •Only patients treated with dual SGLT2i and RAAS therapy before inclusion
- •Signed informed consent
- •Patients over 18 years-old
- •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
排除标准
- •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
结局指标
主要结局
GFR slope form inclusion to 3 years
GFR slope form inclusion to 3 years
次要结局
- Difference between groups regarding routine nephrological clinical follow-up (proteinuria, albuminuria, GFR, hematuria, systolic and diastolic blood pressure) at 1, 2 and 3 years
- Difference in proportion of end stage renal disease (GFR< 15mL/min/1.73m²) and deaths
- Proportion of adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia)
- Correlations between hydroxychloroquine trough levels (mean trough level and maximum trough level) and evolution of proteinuria, eGFR, blood pressure
- Correlations between hydroxychloroquine trough levels (mean trough level and maximum trough level) and adverse events (QT interval measurement, any adverse event, serious adverse events)
- Biocollection of plasma, serum, urine and DNA samples
研究者
Project manager
Scientific
Centre Hospitalier Universitaire De Saint Etienne
研究点 (14)
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