Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
6 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2009
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 11, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 11, 2009
August 1, 2009
3.3 years
August 10, 2009
August 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
16~24 weeks
Study Arms (2)
prednisone, MMF and FK506
EXPERIMENTALprednisone
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- Urinary protein≥1.0g/24h
- Biopsy-proved FSGS
- Age≥16years
- Understanding of the content of this study，signing informed consent form
- Adherence to drug taking and being able to be long-term followed up
You may not qualify if:
- Sharp deterioration of renal function
- Refractory hypertension
- Secondary FSGS
- Serious disease of liver，active stage of viral hepatitis，or AST、ALT≥2.5 times of baseline
- Serious myelosuppression
- Being unable to be long-term followed up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The second affiliated hospital of medical college, Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, 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 CHAIR
Baosong Gui, MD
The second affiliated hospital of Medical College, Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 11, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 11, 2009
Record last verified: 2009-08