- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02351752
Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Beijing
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BeiJing, Beijing, China, 100034
- Peking University First Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary IgA nephopathy
- age 18-75 years
- proteinuria range from 0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB
- eGFR>30ml/min/1.73m2
Exclusion Criteria:
- immune suppressive agent in recent one years
- crescent glomerulonephritis, might use immune suppressive agent
- chronic hepatic disease
- myocardial infarction
- malignant hypertension
- stroke
- malignant tumor
- retinopathy
- other contraindication of Hydroxychloroquine
- pregnancy and breastfeeding women
- life expectancy for less than 6 months
- in other clinical trials
- not suitable for the study judged by investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hydroxychloroquine Sulfate
Hydroxychloroquine Sulfate 0.1 Tid (eGFR 30-59), 0.2 Bid(eGFR >60)
|
Hydroxychloroquine Sulfate: 0.1 Tid(eGFR 30-59);0.2
Bid (eGFR>60)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
proteinuia
Time Frame: total four months(proteinic will recorded every 2 months )
|
total four months(proteinic will recorded every 2 months )
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hong Zhang, PhD,MD, Peking University First Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Urologic Diseases
- Nephritis
- Glomerulonephritis
- Kidney Diseases
- Glomerulonephritis, IGA
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Hydroxychloroquine
Other Study ID Numbers
- 2014【851】
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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