FSGS
Conditions
Keywords
FSGS, FK506, CTX
Brief summary
This is a prospective,multicentre study to compare the efficacy, safety, tolerability and relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis (FSGS).
Detailed description
1. Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients. 2. To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.
Interventions
DRUGFK506
FK506:0.05-0.1mg/kg/d
DRUGCyclophosphamide
CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.
Sponsors
Nanjing University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients with a diagnosis of FSGS. * Patients with a proteinuria ≥ 3.5g/24h,and blood albumin \<30g/L,and Scr\< 2.3 mg/dl and eGFR\>30ml/min per 1.73m2. * Patients who signed written informed consent form (patients less than 18 years old with their parents/legal representative's signatures), and have given their consent to follow all study procedures and follow-up.
Exclusion criteria
* Patients who have received treatment of FK506 in latest 2 month or the cumulative dose CTX≥6 g. * Patients who are known to be allergic to a macrolide. * Patients who have active hepatitis. * Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit . * Patients with blood leukocyte \< 3000/ul. * Patients with kidney disease family history * Patients with 2 type diabetes. * Patients with obesity whose BMI\>28kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rates of the complete remission during the induction phase | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| the total remission rates | 18 months |
Countries
China
Outcome results
None listed