Back to resultsTacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
Primary Purpose
Focal Glomerulosclerosis
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Focal Glomerulosclerosis focused on measuring Idiopathic Focal Segmental Glomerulosclerosis, Treatment, Steroids
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tacrolimus
Arm Description
Outcomes
Primary Outcome Measures
To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis
Secondary Outcome Measures
To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis
Full Information
NCT ID
NCT00302536
First Posted
March 13, 2006
Last Updated
February 8, 2012
Sponsor
Nanjing University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00302536
Brief Title
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
Official Title
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Withdrawn
Why Stopped
There was less patients recruited.
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Nanjing University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with idiopathic focal segmental glomerulosclerosis.
Detailed Description
Primary FSGS is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. Steroids, which are currently used to treat the disease, are effective in part of patients. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with FSGS. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cells, for example, tacrolimus, may be effective in the treatment of primary FSGS. The experience with Tacrolimus (FK506) in the treatment of patients with FSGS has been limited to uncontrolled trials in adult patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Glomerulosclerosis
Keywords
Idiopathic Focal Segmental Glomerulosclerosis, Treatment, Steroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Tacrolimus, Prograf
Intervention Description
Tacrolimus
Primary Outcome Measure Information:
Title
To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis
Time Frame
18 months
Secondary Outcome Measure Information:
Title
To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-hong Liu, M.D.
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35224732
Citation
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.
Results Reference
derived
Learn more about this trial
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
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