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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: tripterygium wilfordii (TW) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.
Study Start Date : March 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Urinalysis
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: immunosuppressor Drug: tripterygium wilfordii (TW)
90 mg/d for 6 months
Other Name: tripterygium wilfordii


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The percentage of total effect of the 3 groups and adverse event within the follow-up periods. [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885547


Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Principal Investigator: Zheng Tang, Doctor Nanjing University School of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00885547     History of Changes
Other Study ID Numbers: NJCT-0904
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Glomerulonephritis
Nephritis
Kidney Diseases
 Urologic Diseases
Autoimmune Diseases
Immune System Diseases