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Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study

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ClinicalTrials.gov Identifier: NCT02351752
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
LLiu, Peking University First Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Primary IgA Nephropathy Drug: Hydroxychloroquine Sulfate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal Disease
Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Experimental: Hydroxychloroquine Sulfate
Hydroxychloroquine Sulfate 0.1 Tid (eGFR 30-59), 0.2 Bid(eGFR >60)
Drug: Hydroxychloroquine Sulfate
Hydroxychloroquine Sulfate: 0.1 Tid(eGFR 30-59);0.2 Bid (eGFR>60)




Primary Outcome Measures :
  1. proteinuia [ Time Frame: total four months(proteinic will recorded every 2 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:

  1. primary IgA nephopathy
  2. age 18-75 years
  3. proteinuria range from 0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB
  4. eGFR>30ml/min/1.73m2

Exclusion Criteria:

  1. immune suppressive agent in recent one years
  2. crescent glomerulonephritis, might use immune suppressive agent
  3. chronic hepatic disease
  4. myocardial infarction
  5. malignant hypertension
  6. stroke
  7. malignant tumor
  8. retinopathy
  9. other contraindication of Hydroxychloroquine
  10. pregnancy and breastfeeding women
  11. life expectancy for less than 6 months
  12. in other clinical trials
  13. 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): NCT02351752


Locations
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China, Beijing
Peking University First Hospital
BeiJing, Beijing, China, 100034
Sponsors and Collaborators
LLiu
Investigators
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Study Director: Hong Zhang, PhD,MD Peking University First Hospital
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Responsible Party: LLiu, Renal Division, Peking University First Hospital, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02351752    
Other Study ID Numbers: 2014【851】
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents