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

Sponsor

Nanjing University School of Medicine (Other)

Overall Status

Terminated

CT.gov ID

NCT01451489

Collaborator

(none)

Enrollment

Location

Arms

60.6

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
FSGS	Drug: FK506 Drug: Cyclophosphamide	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 13, 2011

Actual Primary Completion Date :

Mar 23, 2016

Actual Study Completion Date :

Oct 29, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cyclophosphamide CTX	Drug: Cyclophosphamide CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months. Other Names: CTX
Experimental: FK506 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 FK506:0.05-0.1mg/kg/d Other Names: Tacrolimus,Prograf

Arm

Intervention/Treatment

Active Comparator: Cyclophosphamide

CTX

Drug: Cyclophosphamide

CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.

Other Names:

CTX

Experimental: FK506

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

FK506:0.05-0.1mg/kg/d

Other Names:

Tacrolimus,Prograf

Outcome Measures

Primary Outcome Measures

the rates of the complete remission during the induction phase [6 months]

Secondary Outcome Measures

the total remission rates [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.