Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
NCT00956059 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2009-08-11
Summary
The aim of this clinical trial is to determine the effect and security of low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis.
Conditions
- Focal Segmental Glomerulosclerosis
Interventions
- DRUG
-
prednisone, FK506, MMF
1.in the initial 3 months,prednisone dosage is 30mg per day;in the following 4\~6 months,prednisone dose decreased to 20mg per day,then tapered gradually to 10mg per day;2.the initial dosage of FK506 is 0.2mg/kg/d, twice per day,the maintenance dosage is adjust to the serum concentration of FK506 (is maintained at the level of 6\~10μg/L);3. the initial dosage of MMF is 1.0g, twice per day,then reduce to 0.75 g, twice per day after 3 months
- DRUG
-
In the initial 16\~24 weeks,prednisone is given at full dose of 1mg/kg/d,then prednisone is tapered gradually,the whole course of treatment is 52 weeks
Sponsors & Collaborators
-
Xi'an Jiaotong University
lead OTHER
Principal Investigators
-
Baosong Gui, MD · The second affiliated hospital of Medical College, Xi'an Jiaotong University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- China
Study Locations
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