Primary IgA Nephropathy Clinical Trial
Official title:
Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal Disease
IgA nephropathy is the most common type of primary glomerulonephritis and might caused by
deposition of immune complex containing IgA in mesangium and causing local immune
activation. Hydroxychloroquine reduces the activation of dendritic cells and the
inflammatory process and showed the potential effect of treatment of patients with IgA
nephropathy.
The investigators study will recruite IgA nephropathy patients with proteinuria range from
0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were
treated with Hydroxychloroquine 300-400mg/d according to eGFR. The proteinuria will recorded
every two months and total four months. Then, the drug will be stopped for two months for
observation of change of proteinuria.
Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis
worldwide. Several studies indicated that 6-43% of IgA nephropathy patients would develop
end-stage kidney disease (ESKD) over a period of 10 years. The clinical risk factors for
progression are hypertension, protienuria, impaired renal function and histologic lesions at
presentation. There is no well accepted optimal therapy for patients with IgA. Current
established therapies include full RAS inhibition and optimal blood pressure control for
patients with proteinuria and/or hypertension.
Hydroxychloroquine has been used for many years to treat malaria. It is also used to treat
systemic lupus erythematosus, rheumatic disorders like rheumatoid arthritis and Sjögren's
Syndrome. Recently, several studies found that Hydroxychloroquine could reduce the risk of
ESRD in patients with lupus nephrits. The mechanism of the treatment wasn't well known so
far. Some investigators found that Hydroxychloroquine increases lysosomal pH in antigen
presenting cells. In inflammatory conditions, it blocks toll-like receptors on plasmacytoid
dendritic cells (PDCs). Toll-like receptor 9 (TLR 9), which recognizes DNA-containing immune
complexes, leads to the production of interferon and causes the dendritic cells to mature
and present antigen to T cells. Hydroxychloroquine, by decreasing TLR signaling, reduces the
activation of dendritic cells and the inflammatory process.
The pathogenesis of IgA nephropathy included the deposition of immune complex containing IgA
in mesangium and causing local immune activation and injury to kidney. Therefore,
Hydroxychloroquine might have the potential effect of anti-inflammation in patients with IgA
nephropathy, reduced the proteinuria and had the renal protect effect.
Our study will recruite IgA nephropathy patients with proteinuria range from 0.75 to 3.5g/d
even after three-month treatment by sufficient ACEi/ARB. The patients were treated with
Hydroxychloroquine 300-400mg/d according to eGFR. The proteinuria will recorded every two
months and total four months. Then, the drug will be stopped for two months for observation
of change of proteinuria.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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