The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis
NCT ID: NCT01451489
Last Updated: 2017-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
70 participants
INTERVENTIONAL
2011-10-13
2016-10-29
Brief Summary
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Detailed Description
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2. To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cyclophosphamide
CTX
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.
FK506
0.05-0.1mg/kg/d;adjust the dose according the serum concentration(aim 5-10ng/ml),maximum dose 6mg/day;divided in twice, interval 12 hours.
FK506
FK506:0.05-0.1mg/kg/d
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
14 Years
65 Years
ALL
No
Sponsors
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Nanjing University School of Medicine
OTHER
Responsible Party
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Zhi-Hong Liu, M.D.
Professor
Principal Investigators
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Zhihong Liu, MD
Role: STUDY_DIRECTOR
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Locations
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Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China
Countries
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References
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Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
Other Identifiers
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NJCT-1101
Identifier Type: -
Identifier Source: org_study_id
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