Study Stopped
There was less patients recruited.
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with idiopathic focal segmental glomerulosclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2006
Longer than P75 for not_applicable
1 active site
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
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFebruary 9, 2012
September 1, 2010
4.2 years
March 13, 2006
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis
18 months
Secondary Outcomes (1)
To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis
18 months
Study Arms (1)
Tacrolimus
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age 14-50 years at onset of signs or symptoms of FSGS
- Biopsy proven FSGS
- Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2
- Urine protein \> 3.5 g/24h
- Biopsy confirmed primary FSGS (including all subtypes)
- Willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
You may not qualify if:
- Secondary FSGS
- Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Malignancy
- Previously diagnosed diabetes mellitus type 1 or 2
- Clinical evidence of cirrhosis or chronic active liver disease
- History of significant gastrointestinal disorder
- Allergy to study medications, and Inability to consent/assent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002, China
Related Publications (1)
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
PMID: 35224732DERIVED
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 13, 2006
First Posted
March 14, 2006
Study Start
March 1, 2006
Primary Completion
May 1, 2010
Study Completion
September 1, 2010
Last Updated
February 9, 2012
Record last verified: 2010-09