Therapeutic effect of Hydroxychloroquine on IgA Nephropathy course QUIgAN Study

Conditions

IgA nephropathy

Brief summary

GFR slope form inclusion to 3 years

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGPLAQUENIL 200 mg comprimés pelliculés sulfate d’hydroxychloroquine

DRUGplacebo plaquenil pharmaceutical form: tablets active substance: not applicable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
GFR slope form inclusion to 3 years	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

France

Outcome results

None listed