The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis

Study Overview
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Brief Summary
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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
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Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients. To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.

Official Title
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A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis

Conditions
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FSGS

Intervention / Treatment
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* Drug: FK506
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclophosphamide<br>CTX | Drug: Cyclophosphamide<br>* CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.<br>* Other names: CTX;|
| Experimental: FK506<br>0.05-0.1mg/kg/d;adjust the dose according the serum concentration(aim 5-10ng/ml),maximum dose 6mg/day;divided in twice, interval 12 hours. | Drug: FK506<br>* FK506:0.05-0.1mg/kg/d<br>* Other names: Tacrolimus,Prograf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rates of the complete remission during the induction phase |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total remission rates |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FSGS, FK506, CTX