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Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis

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: NCT00885547
Recruitment Status : Terminated (low-rate of enrollment)
First Posted : April 22, 2009
Last Update Posted : April 2, 2015
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine

Tracking Information
First Submitted Date  ICMJE April 20, 2009
First Posted Date  ICMJE April 22, 2009
Last Update Posted Date April 2, 2015
Study Start Date  ICMJE March 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
The percentage of total effect of the 3 groups and adverse event within the follow-up periods. [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis
Official Title  ICMJE Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.
Brief Summary

The purpose of this study is to:

  1. To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis.
  2. To evaluate the safety and tolerability of TW.
Detailed Description Patients who fit the inclusion criteria will be randomly divided into three groups: TW group (TW at dosage of 90 mg/d), ARB group (the control group, valsartan at dosage of 160 mg/d) and combined treatment group (TW at dosage of 60 mg/d and valsartan at dosage of 80 mg/d).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE IgA Nephropathy
Intervention  ICMJE Drug: tripterygium wilfordii (TW)
90 mg/d for 6 months
Other Name: tripterygium wilfordii
Study Arms  ICMJE Experimental: immunosuppressor
Intervention: Drug: tripterygium wilfordii (TW)
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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 20, 2009)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18-60 years old but no requirement for gender
  2. All well fit the Diagnostic Criteria for Primary IgAN and IgAN with asymptomatic abnormal urinalysis
  3. Informed consent is obtained from each research subject who agrees to conduct a periodic follow-up according to the research arrangement

Exclusion Criteria:

  1. Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on
  2. Some secondary kidney diseases like diabetic nephropathy or other systemic diseases which may effect the pathologic and physiological function of kidney like hypertension and arteriosclerosis
  3. Severe infection
  4. Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal
  5. Women during pregnancy and lactation
  6. Patients need to procreation lately
  7. Patients treated with TW or ARB within 4 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT00885547
Other Study ID Numbers  ICMJE NJCT-0904
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhi-Hong Liu, M.D., Nanjing University School of Medicine
Study Sponsor  ICMJE Nanjing University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zheng Tang, Doctor Nanjing University School of Medicine
PRS Account Nanjing University School of Medicine
Verification Date March 2015

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