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

This study is currently recruiting participants.
Verified March 2013 by Nanjing University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01161459
First received: July 12, 2010
Last updated: August 30, 2013
Last verified: March 2013
  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

Resource links provided by NLM:


Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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 + Prednisone 30mg/d

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161459

Contacts
Contact: Ke Zuo, Master 00862580860734 ext 210002 alexzuo1982@gmail.com

Locations
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   
Sponsors and Collaborators
Zhi-Hong Liu, M.D.
Investigators
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: August 30, 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
Prednisone
Tacrolimus
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014