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A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT02942381
Recruitment Status : Completed
First Posted : October 24, 2016
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Lijun Liu, Clinical Professor, Peking University First Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
IgA Patients Hydroxychloroquine Drug: Hydroxychloroquine Sulfate Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : September 13, 2016
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : January 8, 2018


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
Drug: 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 )

Placebo Comparator: Placebo
Placebo and supportive treatment
Drug: Placebo



Primary Outcome Measures :
  1. Proteinuria (g/d) [ Time Frame: every two months(total six months) ]

Secondary Outcome Measures :
  1. Albuminuria and creatinine ratio(mg/g) [ Time Frame: every two months(total six months) ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942381


Locations
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China, Beijing
Peking University First Hospital
BeiJing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lijun Liu, Clinical Professor, Peking University First Hospital Research department, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02942381     History of Changes
Other Study ID Numbers: 2016(1057)
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents