Skip to main content
Clinical Trials/NCT01161459
NCT01161459CompletedNot Applicable

Research Institute of Nephrology, Jinling Hospital

Zhi-Hong Liu, M.D.1 site in 1 country100 target enrollmentStarted: June 2010Last updated:
Conditions
Interventions
Drugs

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

Experimental

120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months

Intervention: Tripterygium wilfordii (Drug)

FK506

Active Comparator

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

Sponsor
Zhi-Hong Liu, M.D.
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Zhi-Hong Liu, M.D.

professor

Nanjing University School of Medicine

Study Sites (1)

Loading locations...

Similar Trials