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

Not Applicable

Terminated

• Conditions: FSGS
• Interventions: Drug: FK506; Drug: Cyclophosphamide

• Registration Number: NCT01451489
• Lead Sponsor: Nanjing University School of Medicine

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.

Study Timeline

• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-10-11
• Study Start: 2011-10-13
• Study First Posted: 2011-10-13
• Primary Completion: 2016-03-23
• Study Completion: 2016-10-29
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FK506	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.
Cyclophosphamide	Cyclophosphamide	CTX

Primary Outcome Measures

Name	Time	Method
the rates of the complete remission during the induction phase	6 months

Secondary Outcome Measures

Name	Time	Method
the total remission rates	18 months

Trial Locations

Locations (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine; 🇨🇳 Nanjing, Jiangsu, China