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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01451489 |
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Date of registration:
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05/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis
FSGS |
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Scientific title:
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A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis |
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Date of first enrolment:
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October 13, 2011 |
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Target sample size:
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70 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01451489 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Zhihong Liu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine |
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Key inclusion & exclusion criteria
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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.
Age minimum:
14 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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FSGS
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Intervention(s)
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Drug: Cyclophosphamide
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Drug: FK506
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Primary Outcome(s)
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the rates of the complete remission during the induction phase
[Time Frame: 6 months]
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Secondary Outcome(s)
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the total remission rates
[Time Frame: 18 months]
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Secondary ID(s)
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NJCT-1101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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