Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.
Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f
1 other identifier
interventional
300
1 country
1
Brief Summary
The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJuly 11, 2014
July 1, 2014
1.2 years
June 22, 2014
July 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients reaching remission
(i) complete remission was defined as the absence of proteinuria (24-h urine protein \< 0.4 g/24 h), serum albumin \>35 g/L and Scr \< 1.24 mg/ dL; (ii) partial remission was defined as a 24-h urine protein ≤ 3.5 g/24 h and a decline of \>50% of the baseline value with an Scr elevation of \<15% of the baseline value; (iii) no response was defined as a 24-h urine protein \>3.5 g/24h, or a decline \< 50% of base- line value or increase and/or an Scr level \>50% of the baseline value
one year
Secondary Outcomes (1)
Renal survival
one year
Other Outcomes (1)
adverse event
one year
Study Arms (2)
TWH for the treatment of IgAN
EXPERIMENTALInterventions :The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
MMF for IgAN
ACTIVE COMPARATORMMF for the treatment of IgAN for 6 months
Interventions
The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months
Eligibility Criteria
You may qualify if:
- 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
- (×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
You may not qualify if:
- severe infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The second Xiangya Hospital of CSU
Changsha, Hunan, 410011, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shenghua Zhou, MD
the second xiangya hospital of CSU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Nephrology Institute
Study Record Dates
First Submitted
June 22, 2014
First Posted
July 11, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
July 11, 2014
Record last verified: 2014-07