To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)

This study has been completed.

First Received: August 16, 2007 Last Updated: January 25, 2010 History of Changes

Sponsor:	Nanjing University School of Medicine
Information provided by:	Nanjing University School of Medicine
ClinicalTrials.gov Identifier:	NCT00518219

Purpose

The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment of heavy proteinuria of membranous nephropathy.

Condition	Intervention	Phase
Membranous Nephropathy	Drug: TW	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	To Compare the Efficacy and Safety of TW vs Valsartan in the MN

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:

To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To investigate the safety and tolerability of TW vs ARB in treatment of MN [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	68
Study Start Date:	July 2007
Study Completion Date:	September 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
immunosuppressor: Experimental TW 120mg/d，Valsartan,160mg/d	Drug: TW TW,120mg/d

Detailed Description:

Membranous nephropathy with heavy proteinuria have high risks of progressing to CRF.

Tripterygium (TW) is a Chinese traditional patent drugs, it can reduce proteinuria of chronic glomerular nephritis,such as IgA nephropathy. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus Valsartan in the treatment of heavy proteinuria of MN.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Biopsy-proven idiopathic membranous nephropathy
Nephrotic syndrome with proteinuria (> 4 g/day) and serum albumin < 30 g/dl
Age over 18 with informed consent

Exclusion Criteria:

Patient with abnormal liver function tests
Prior therapy with sirolimus, CSA, MMF, tacrolimus or azathioprin, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days,
Active/serious infection,
Patient with hepatitis B surface antigen or who is hepatitis C antibody positive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518219

Locations

China, Jiangsu
Research Institute of Nephrology
Nanjing, Jiangsu, China, 210002

Sponsors and Collaborators

Nanjing University School of Medicine

Investigators

Principal Investigator:

Zhihong Liu, Master

Jinling Hospital, China

More Information

No publications provided

Responsible Party:	Nanjing University School of Medicine ( Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine )
Study ID Numbers:	NJCT-0702
Study First Received:	August 16, 2007
Last Updated:	January 25, 2010
ClinicalTrials.gov Identifier:	NCT00518219 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:

TW
Valsartan
treatment
membranous nephropathy
proteinuria

Additional relevant MeSH terms:

Glomerulonephritis
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Therapeutic Uses
Nephritis

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

ClinicalTrials.gov processed this record on February 08, 2010