|
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: |
NCT00801463 |
|
Date of registration:
|
02/12/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
|
|
Scientific title:
|
Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis |
|
Date of first enrolment:
|
January 2009 |
|
Target sample size:
|
67 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00801463 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel 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, |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age 18-60 years at onset of signs or symptoms of FSGS
- Urine protein = 3.5 g/24 h
- Estimated glomerular filtration rate (GFR) = 40 ml/min/1.73 m2, serum
creatinine<2.5mg/dl
- Biopsy confirmed as idiopathic 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, Cyclosporine, MMF, azathioprin, cytoxan, chlorambucil,
levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Malignancy
- Previously diagnosed as diabetes mellitus type 1 or 2, or abnormal carbohydrate
tolerance
- Peripheral white blood cells < 3000/ul
- Clinical evidence of cirrhosis or chronic active liver diseases
- History of significant gastrointestinal disorder
- Allergy to study medications, and Inability to consent/assent
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Proteinuria
|
|
Focal Segmental Glomerulosclerosis
|
|
Intervention(s)
|
|
Drug: tripterygium wilfordii (TW)
|
|
Primary Outcome(s)
|
|
To assess the efficacy and safety of TW in the treatment of FSGS
[Time Frame: 12 months]
|
|
Secondary ID(s)
|
|
NJCT-0801
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|