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Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01161459
First received: July 12, 2010
Last updated: May 29, 2014
Last verified: May 2014

July 12, 2010
May 29, 2014
June 2010
April 2012   (final data collection date for primary outcome measure)
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01161459 on ClinicalTrials.gov Archive Site
Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Same as current
Not Provided
Not Provided
 
Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
Research Institute of Nephrology, Jinling Hospital

The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy.

To investigate the safety and tolerability of Tripterygium wilfordii plus steroid

Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with tacrolimus plus steroid in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a traditional herbal extraction, Tripterygium wilfordii, plus steroid in reducing the amount of protein in the urine in patients with membranous nephropathy. A hundred patients with biopsy-proven membranous nephropathy will be recruited. They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of Tripterygium wilfordii in the treatment of membranous nephropathy. Half of them will be treated with oral Tripterygium wilfordii plus steroids for 6 months, followed by 6 months of maintenance, and the other half treated with tacrolimus plus steroid as positive contrast. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day and serum albumin>35g/L. This study will explore the potential role of Tripterygium wilfordii in the treatment of membranous nephropathy, it's cost less .

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Membranous Nephropathy
  • Drug: Tripterygium wilfordii
    Tripterygium wilfordii 120mg/d Prednisone 30mg/d
    Other Name: TW
  • Drug: FK506
    capsule
    Other Name: Tacrolimus + Prednisone 30mg/d
  • Experimental: Tripterygium wilfordii
    120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months
    Intervention: Drug: Tripterygium wilfordii
  • Active Comparator: FK506
    Intervention: Drug: FK506
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2013
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Biopsy-proven idiopathic membranous nephropathy
  2. Nephrotic syndrome with proteinuria ( > 3.5 g/day) and serum albumin < 30 g/dl
  3. Age 18-65 years with informed consent

Exclusion Criteria:

  1. Patient with elevated serum creatinine concentration
  2. Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
  3. Active/serious infection
  4. Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
  5. Patient who is diabetic
  6. Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01161459
NJCT-1004
Yes
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
Zhi-Hong Liu, M.D.
Not Provided
Principal Investigator: Zhihong Liu, Master Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing University School of Medicine
May 2014

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