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

FSGS Clinical Trial

— FSGS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01451489
• Other study ID #: NJCT-1101
• Status: Terminated
• Phase: N/A
• First received: August 5, 2011
• Last updated: March 22, 2017
• Start date: October 13, 2011
• Est. completion date: October 29, 2016

Study information

• Verified date: March 2017
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: October 29, 2016
• Est. primary completion date: March 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• FSGS
• Glomerulosclerosis, Focal Segmental

Intervention

Drug:
• FK506
FK506:0.05-0.1mg/kg/d
• 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.

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rates of the complete remission during the induction phase		6 months
Secondary	the total remission rates		18 months