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

This study has been withdrawn prior to enrollment.
(There were so many patients drop-out.)
Sponsor:
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00885547
First received: April 20, 2009
Last updated: August 8, 2011
Last verified: April 2009
  Purpose

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 Intervention
IgA Nephropathy
Drug: tripterygium wilfordii (TW)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.

Resource links provided by NLM:


Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The percentage of total effect of the 3 groups and adverse event within the follow-up periods. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: immunosuppressor Drug: tripterygium wilfordii (TW)
90 mg/d for 6 months
Other Name: tripterygium wilfordii

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885547

Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Principal Investigator: Zheng Tang, Doctor Nanjing University School of Medicine
  More Information

No publications provided

Responsible Party: Zheng Tang, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00885547     History of Changes
Other Study ID Numbers: NJCT-0904
Study First Received: April 20, 2009
Last Updated: August 8, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014