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

Idiopathic Membranous Nephropathy Clinical Trial

Official title:

Research Institute of Nephrology, Jinling Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161459
• Other study ID #: NJCT-1004
• Status: Completed
• Phase: N/A
• First received: July 12, 2010
• Last updated: May 29, 2014
• Start date: June 2010
• Est. completion date: October 2013

Study information

• Verified date: May 2014
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Intervention

Drug:
• Tripterygium wilfordii
Tripterygium wilfordii 120mg/d Prednisone 30mg/d
• FK506
capsule

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhi-Hong Liu, M.D.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy		18 months	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	18 months	Yes