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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02942381 |
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Date of registration:
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14/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy
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Scientific title:
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Date of first enrolment:
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September 13, 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02942381 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hydroxychloroquine
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IgA Patients
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Intervention(s)
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Drug: Hydroxychloroquine Sulfate
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Drug: Placebo
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Primary Outcome(s)
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Proteinuria (g/d)
[Time Frame: every two months(total six months)]
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Secondary Outcome(s)
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Albuminuria and creatinine ratio(mg/g)
[Time Frame: every two months(total six months)]
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Secondary ID(s)
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2016(1057)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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