- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02942381
A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy
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, proteinuria, 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 nephritis. 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.
The investigators study will recruit 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 200-400mg/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 2
Contacts and Locations
Study Locations
-
-
Beijing
-
BeiJing, Beijing, China, 100034
- Peking University First Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary IgA nephropathy
- 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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hydroxychloroquine Sulfate
200mg Bid (eGFR>60 ml/min/1.73m2),
100mg Tid (eGFR45-59 ml/min/1.73m2),
100mg Bid (eGFR 30-44 ml/min/1.73m2)
and supportive treatment
|
200mg Bid (eGFR>60 ml/min/1.73m2
), 100mg Tid(eGFR45-59 ml/min/1.73m2
), 100mg Bid(eGFR 30-44 ml/min/1.73m2
)
|
Placebo Comparator: Placebo
Placebo and supportive treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proteinuria (g/d)
Time Frame: every two months(total six months)
|
every two months(total six months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Albuminuria and creatinine ratio(mg/g)
Time Frame: every two months(total six months)
|
every two months(total six months)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016(1057)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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