Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-05 @ 5:39 PM
Study NCT ID:
NCT01161459
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2010-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
Sponsor:
Zhi-Hong Liu, M.D.
Organization:
Study Overview
Official Title:
Research Institute of Nephrology, Jinling Hospital
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: