Research Institute of Nephrology, Jinling Hospital
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
Study Overview
Brief 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
Detailed 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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Biopsy-proven idiopathic membranous nephropathy
- •Nephrotic syndrome with proteinuria ( > 3.5 g/day) and serum albumin < 30 g/dl
- •Age 18-65 years with informed consent
Exclusion Criteria
- •Patient with elevated serum creatinine concentration
- •Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, 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
- •Patient who is diabetic
- •Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Arms & Interventions
Tripterygium wilfordii
120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months
Intervention: Tripterygium wilfordii (Drug)
FK506
Intervention: FK506 (Drug)
Outcomes
Primary Outcomes
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
Time Frame: 18 months
Secondary Outcomes
- Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid(18 months)
Investigators
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine
