Prospective Study of Tripterygium Wilfordii (TW) in Treatment of IgA Nephropathy (IgAN) With Asymptomatic Abnormal Urinalysis - Full Text View

Sponsored by:	Nanjing University School of Medicine
Information provided by:	Nanjing University School of Medicine
ClinicalTrials.gov Identifier:	NCT00885547

Purpose

The purpose of this study is to:

To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis.
To evaluate the safety and tolerability of TW.

Condition	Intervention
IGA Nephropathy	Drug: tripterygium wilfordii (TW) Drug: valsartan Drug: TW (60 mg) Drug: Valsartan

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Clinical Study of Tripterygium Wilfordii in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.

Resource links provided by NLM:

Drug Information available for: Valsartan

U.S. FDA Resources

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
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TW: Experimental TW at dosage of 90 mg/d	Drug: tripterygium wilfordii (TW) tripterygium wilfordii 90 mg/d for 6 months
ARB: Active Comparator ARB group (the control group, valsartan at dosage of 160 mg/d)	Drug: valsartan valsartan at dosage of 160 mg/d
Combined Treatment: Experimental Combined treatment group (TW at dosage of 60 mg/d and valsartan at dosage of 80 mg/d)	Drug: TW (60 mg) tripterygium wilfordii 60 mg/d Drug: Valsartan valsartan at dosage of 80 mg/d

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:

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

Exclusion Criteria:

Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on
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
Severe infection
Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal
Women during pregnancy and lactation
Patients need to procreation lately
Patients treated with TW or ARB within 4 months

Contacts and Locations

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

Contacts

Contact: Chunlei Luo, Master

0086-25-80860734

njrin@nju.edu.cn

Locations

China, Jiangsu
Research Institute of Nephrology,Jinling Hospital,	Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Chunlei Luo, Master 0086-25-80860734 luo-chunlei@163.com

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

Study placed in the following topic categories:

Glomerulonephritis
Autoimmune Diseases
Urologic Diseases
Nephritis
Glomerulonephritis, IGA
Cardiovascular Agents

Kidney Diseases
Tripterygium
Antihypertensive Agents
Valsartan
Berger Disease

Additional relevant MeSH terms:

Glomerulonephritis
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Therapeutic Uses
Nephritis

Glomerulonephritis, IGA
Cardiovascular Agents
Kidney Diseases
Antihypertensive Agents
Pharmacologic Actions
Valsartan

ClinicalTrials.gov processed this record on August 24, 2009