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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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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-TRC-10001024 |
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Date of registration:
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2010-09-14 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis
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Scientific title:
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Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis |
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Date of first enrolment:
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2008-01-01 |
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Target sample size:
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group A:30;group B:30; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=8514 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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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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Nan Chen
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Address:
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Nephrology Department, Shanghai Jiaotong university affiliated Ruijin Hospital, No.197, Second Ruijin Road, Luwan District, Shanghai, China.
200025
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Telephone:
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+86 021 64370045 |
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Email:
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chen-nan@medmail.com.cn |
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Affiliation:
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Name:
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Hong Ren
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Address:
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Nephrology Department, Shanghai Jiaotong university affiliated Ruijin Hospital, No.197, Second Ruijin Road, Luwan District, Shanghai, China.
200025
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Telephone:
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+86 021 64370045 |
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Email:
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renhong66@126.com |
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Affiliation:
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Nephrology department, Shanghai Jiaotong university affiliated Ruijin Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Written informed consent;
2. Age 18-75 years old(Including 18 and 75 years);
3. The clinical and renal biopsy confirmed diagnosis of steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis; steroid-resistant: patients who received prednisone or prednisolone(1mg/kg/d) treatment for 12 weeks did not remissionsteroid-dependent: patients relapse when reducted to a certain dose of prednisone;
4. 24h urine protein> 1.5 g, and GFR> 30ml/min.;
5. Those who have not used other than in addition to glucocorticoid immunosuppressant or be discontinued for 3 months;
6. Blood pressure can be controlled over 135/85mmHg.
Exclusion criteria: 1. Secondary FSGS;
2. Application within three months of glucocorticoid were informal;
3. In addition to glucocorticoid, patients have used other immunosuppressant;
4. Blood pressure can not be controlled over 135/85mmHg after antihypertensive treatment;
5. Females who are pregnant or breast-feeding;
6. Patients those with acute renal failure had receives reatment of hemodialysis;
7. Severe infection, heart failure and central nervous system disorders;
8. Severe Immunodeficiency, active gastrointestinal disease, or myelodysplastic;
9. Liver dysfunction cause from other causes;
10. Positive serum parameters for hepatitis B or C;
11. Serum WBC < 3.5×10^9/L, PLT<5*10^12/L;
12. Cancer or an individual history of cancer;
13. Mental illness;
14.Poor compliance, or unwilling to accept treatment in this study.
Age minimum:
18
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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primary focal segmental glomerulosclerosis
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Intervention(s)
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group A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ;
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Primary Outcome(s)
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blood and urine routine examination;24-hour urine protein;Serum lipid (Triglyceride, Cholesterol);Liver and kidney function;FK506 concentratio;
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Source(s) of Monetary Support
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Shanghai Jiaotong University Affiliated Ruijin Hospital
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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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