Focal Segmental Glomerulosclerosis | Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
Focal Segmental Glomerulosclerosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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 Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Focal Segmental Glomerulosclerosis
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:prednisone, FK506, MMF1.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:prednisoneIn 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
prednisone, MMF and FK506
Start Date: September 2009
Completed Date: December 2012
Primary Outcome: proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
Study sponsors, principal investigator, and references
Principal Investigator: Baosong Gui, MD
Lead Sponsor: Health Science Center of Xi’an Jiaotong University