Status:
TERMINATED
The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis
Lead Sponsor:
Nanjing University School of Medicine
Conditions:
FSGS
Eligibility:
All Genders
14-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2016
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01451489
Start Date
October 13 2011
End Date
October 29 2016
Last Update
March 27 2017
Active Locations (1)
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1
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002