Focal Segmental Glomerulosclerosis
Conditions
Keywords
focal segmental glomerulosclerosis, prednisone, mycophenolate mofetil, FK506
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.
Detailed description
Focal segmental glomerular sclerosis (FSGS) is characterized by heavy proteinuria and nephritic syndrome in clinic. The major pathological change is scarring of the glomerulus that is focal and segmental. The incidence of FSGS is increasing in recent years, but no unified protocol for FSGS treatment has been provided. Corticosteroid is the primary drug for FSGS treatment in clinic. However, corticosteroid treatment has a low response rate as 20% in clinic but some severe side-effects. The side-effects of long-term corticosteroid treatment urged researchers to find more reliable and secure methods for FSGS treatment. The new immunosuppressants shed light on FSGS treatment recently. The usage of immunosuppressants to FSGS treatment is in the preliminary stage and accounts for a few problems. The main problems include the uncertainty of curative effects, the lack of large-scale clinical trial, the side-effects of long-term application, and the high recurrence rate after withdraw. FSGS is immune-induced damage, which includes abnormality of many steps in humoral immunity and cellular immunity. According to it, we designed to inhibit the immune response at multi-targets with Prednisone Combined With MMF and FK506. Thus the dosage of these drugs can be decreased to a secure level for long-term treatment while the side-effects can be controlled well. Prednisone Combined With MMF and FK506 then can be used to FSGS treatment with effectiveness and security.
Interventions
DRUGprednisone, 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
DRUGprednisone
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
Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test | 16~24 weeks |
Countries
China
Contacts
Primary ContactBaosong Gui, MD
Outcome results
None listed