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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: |
NCT02187900 |
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Date of registration:
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22/06/2014 |
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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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Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.
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Scientific title:
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Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02187900 |
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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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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Liyu He , M.D |
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Address:
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Telephone:
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8615802604114 |
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Email:
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heliyu1124@126.com |
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Affiliation:
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Name:
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Youming Peng, M.D |
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Address:
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Telephone:
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8615802604114 |
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Email:
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Affiliation:
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Name:
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Shenghua Zhou, 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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the second xiangya hospital of CSU |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- urinary protein levels =1.0 g/24 h
- estimated glomerular filtration rate (eGFR) =30 ml·min-1·1.73 m-2body surface area by
the MDRD formula (eGFR=194×age-0.287×serum creatinine
- 1.094(×0.739, if female) (where sCr is the serum creatinine, dry chemistry method,
mg/dl))
- peripheral blood white blood cell count =3000×109/L
- no other cause for tubulointerstitial lesions
- no history of immunomodulatory agent intake before renal biopsy
- no systemic infection
- age between 16 and 65 years
Exclusion Criteria:
- severe infections
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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IgA Nephropathy
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Intervention(s)
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Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)
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Drug: Mycophenolate mofetil (MMF)
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Primary Outcome(s)
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Number of patients reaching remission
[Time Frame: one year]
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Secondary Outcome(s)
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Renal survival
[Time Frame: one year]
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Secondary ID(s)
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HNXY201401
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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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