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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.
Register: ClinicalTrials.gov
Last refreshed on: 28 December 2015
Main ID:  NCT02351752
Date of registration: 27/01/2015
Prospective Registration: No
Primary sponsor: LLiu
Public title: Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study
Scientific title: Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal Disease
Date of first enrolment: January 2015
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02351752
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
China
Contacts
Name:     Hong Zhang, PhD,MD
Address: 
Telephone:
Email:
Affiliation:  Peking University First Hospital
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Primary IgA Nephropathy
Intervention(s)
Drug: Hydroxychloroquine Sulfate
Primary Outcome(s)
proteinuia [Time Frame: total four months(proteinic will recorded every 2 months )]
Secondary Outcome(s)
Secondary ID(s)
2014?851?
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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