NCT01451489

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Nanjing University School of Medicine · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• FSGS

Interventions

Type	Name	Description
DRUG	FK506	FK506:0.05-0.1mg/kg/d
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.

Timeline

• Start date: 2011-10-13
• Primary completion: 2016-03-23
• Completion: 2016-10-29
• First posted: 2011-10-13
• Last updated: 2017-03-27

Locations

1 site across 1 country: China