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

Nanjing University School of Medicine

Status

Terminated

Conditions

FSGS

Treatments

Drug: Cyclophosphamide

Drug: FK506

Study type

Interventional

Funder types

Other

Identifiers

NCT01451489

NJCT-1101

Details and patient eligibility

About

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).

Full 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.

Enrollment

70 patients

Sex

All

Ages

14 to 65 years old

Volunteers

No 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.