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Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187900
Recruitment Status : Unknown
Verified July 2014 by Youming Peng, Second Xiangya Hospital of Central South University.
Recruitment status was:  Recruiting
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Youming Peng, Second Xiangya Hospital of Central South University

Tracking Information
First Submitted Date  ICMJE June 22, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date July 11, 2014
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Number of patients reaching remission [ Time Frame: one year ]
(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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Renal survival [ Time Frame: one year ]
Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 10, 2014)
adverse event [ Time Frame: one year ]
liver function test result abnormalities;menstrual disturbance
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.
Official Title  ICMJE Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f
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.
Detailed Description Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis throughout of the world. The disease is characterized by the predominant deposition of polymer Gal-deficient IgA1 immune complex(pGd-IgA1-IC)in the glomeruli which leads to the proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the treatment of IgAN in Chinese patients, but the price is expensive together with some adverse events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in the treatment of CKD, 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE IgA Nephropathy
Intervention  ICMJE
  • Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)
    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.
    Other Name: Multi-glycoside of Tripterygium Wilfordii HOOK. f.
  • Drug: Mycophenolate mofetil (MMF)
    Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months
    Other Name: Mycophenolate mofetil
Study Arms  ICMJE
  • Experimental: TWH for the treatment of IgAN
    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.
    Intervention: Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)
  • Active Comparator: MMF for IgAN
    MMF for the treatment of IgAN for 6 months
    Intervention: Drug: Mycophenolate mofetil (MMF)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02187900
Other Study ID Numbers  ICMJE HNXY201401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Youming Peng, Second Xiangya Hospital of Central South University
Study Sponsor  ICMJE Second Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shenghua Zhou, MD the second xiangya hospital of CSU
PRS Account Second Xiangya Hospital of Central South University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP