Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention |
|---|---|
|
Idiopathic Membranous Nephropathy |
Drug: Tripterygium wilfordii Drug: FK506 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Research Institute of Nephrology, Jinling Hospital |
- 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 ]
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tripterygium wilfordii
120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months
|
Drug: Tripterygium wilfordii
Tripterygium wilfordii 120mg/d Prednisone 30mg/d
Other Name: TW
|
| Active Comparator: FK506 |
Drug: FK506
capsule
Other Name: Tacrolimus
|
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. Eighty-six 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 .
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Ke Zuo, Master | 00862580860734 ext 210002 | alexzuo_3000@yahoo.com.cn |
| China, Jiangsu | |
| Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine | Recruiting |
| Nanjing, Jiangsu, China, 210002 | |
| Contact: Haitao Zhang, Master 00862580860218 ext 210002 haitaozh@yahoo.com.cn | |
| Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine | Recruiting |
| Nanjing, Jiangsu, China, 210002 | |
| Contact: Haitao Zhang, MAster 00862580860218 ext 210002 haitaozh@yahoo.com.cn | |
| Principal Investigator: | Zhihong Liu, Master | Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine |
More Information
No publications provided
| Responsible Party: | Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01161459 History of Changes |
| Other Study ID Numbers: | NJCT-1004 |
| Study First Received: | July 12, 2010 |
| Last Updated: | March 29, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Nanjing University School of Medicine:
|
Idiopathic Membranous Nephropathy Treatment FK506 Tripterygium wilfordii |
Additional relevant MeSH terms:
|
Glomerulonephritis, Membranous Kidney Diseases Glomerulonephritis Nephritis Urologic Diseases Autoimmune Diseases |
Immune System Diseases Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013