|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00302536 |
|
Date of registration:
|
13/03/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
|
|
Scientific title:
|
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental |
|
Date of first enrolment:
|
March 2006 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
http://clinicaltrials.gov/show/NCT00302536 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Zhi-hong Liu, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine |
| | |
|
Key inclusion & exclusion 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
Age minimum:
15 Years
Age maximum:
50 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Focal Glomerulosclerosis
|
|
Intervention(s)
|
|
Drug: Tacrolimus
|
|
Primary Outcome(s)
|
|
To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis
[Time Frame: 18 months]
|
|
Secondary Outcome(s)
|
|
To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis
[Time Frame: 18 months]
|
|
Secondary ID(s)
|
|
NJCT-0604
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|