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

• Status: Terminated
• Trial end date: 2016-10-29
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing University School of Medicine
• Treatments: Cyclophosphamide; Tacrolimus

Criteria

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.