Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy
1 other identifier
interventional
16
1 country
2
Brief Summary
The purpose of this study is:
- To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
- To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2006
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 13, 2006
CompletedFirst Posted
Study publicly available on registry
March 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 3, 2012
February 1, 2012
2.8 years
March 13, 2006
February 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
18 months
Secondary Outcomes (1)
To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.
18 months
Study Arms (1)
FK506
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Biopsy-proven idiopathic membranous nephropathy
- Nephrotic syndrome with proteinuria ( \> 4 g/day) and serum albumin \< 30 g/dl
- Age 18-60 years with informed consent
You may not qualify if:
- Patient with abnormal liver function tests
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002, China
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, 210002, China
Related Publications (1)
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
PMID: 34778952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhi-hong Liu, M.D.
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Institute of Nephrology
Study Record Dates
First Submitted
March 13, 2006
First Posted
March 14, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
February 3, 2012
Record last verified: 2012-02