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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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19 February 2015 |
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Main ID: |
NCT00378443 |
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Date of registration:
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19/09/2006 |
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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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ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT
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Scientific title:
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Date of first enrolment:
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January 2006 |
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Target sample size:
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00378443 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Contacts
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Name:
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Hong Zhang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Renal Division, Peking University First Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. underwent renal biopsy within 1 year before start fo trial;
2. 24 hour urinary protein excretion ranged between 1 to 7 g/d;
3. eGFR, evaluated by MDRD formula, should be higher than 30 ml/min
Exclusion Criteria:
1. crescentic glomerulonephritis;
2. steroid therapy subjected within 1 year before trial;
3. malignant hypertension(DBP> 130 mmHg and/or SBP> 220mmHg), resistant to
anti-hypertensive agents;
4. urinary protein excretion decrease below 1 g/l after run-in period;
5. Myocardial infarction or cerebrovascular accident in 6 months preceding the trial;
6. renovascular disease;
7. diabetes mellitus;
8. Malignancy, severe liver disease, refractory infection;
9. peptic ulcer in active disease phase;
10. pregnancy;
11. other contraindication to the use of ACEi/ ARB or corticosteroid;
12. alcohol abuse or drug addiction
Age minimum:
16 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glomerulonephritis, IGA
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Intervention(s)
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Drug: prednisone + Inhibace/Cozaar
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Drug: Inhibace/Cozaar
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Primary Outcome(s)
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24 hour urinary protein excretion
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Serum creatinine
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Secondary Outcome(s)
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serum urea
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Urinalysis
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serum albumin
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Secondary ID(s)
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[2006]022
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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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