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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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5 February 2018 |
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Main ID: |
ChiCTR1800014719 |
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Date of registration:
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2018-01-31 |
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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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A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis
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Scientific title:
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A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis |
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Date of first enrolment:
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2018-02-01 |
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Target sample size:
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tacrolimus group:24;prednisone group:17; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=25053 |
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Study type:
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Observational study |
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Study design:
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Cohort study
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Phase:
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Retrospective study
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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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Baolian Liu
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Address:
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29 Gaotanyan Main Street, Shapingba District, Chongqing, China
400038
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Telephone:
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+86 13108927455 |
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Email:
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962189205@qq.com |
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Affiliation:
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Third Military Medical University |
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Name:
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Hongwen Zhao
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Address:
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29 Gaotanyan Main Street, Shapingba District, Chongqing, China
400038
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Telephone:
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+86 13983360655 |
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Email:
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358984844@qq.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. All patients were diagnosed with idiopathic focal segmental glomerulosclerosis by clinical and renal biopsy before treatment;
2. proteinuria is greater than 1g/24h;
3. Immunosuppressants were not used within 1 month before starting treatment;
4. All patients were given Angiotensin converting enzyme inhibitors or Angiotensin II receptor 1 blockers;
5. Aged between 12-54 years and sex is not limited.
Exclusion criteria: 1) Hepatitis B, Henoch-Schonlein purpura, systemic lupus erythematosus secondary focal segmental gl omerulosclerosis;
2) Family history of kidney disease and other hereditary nephropathy;
3) Immunosuppressants such as azathioprine, mycophenolate mofetil, cyclosporine A, and leflunomide were taken within 1 month or at the beginning of the study;
4) Contraindications to tacrolimus or high-dose hormones (hepatitis virus carriers, chronic viral hepatitis, any active or serious infection);
5) Medication is not standardized or the treatment time is less than 6 months;
6) Tumor or other serious cases of patients.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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idiopathic focal segmental glomerulosclerosis
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Intervention(s)
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tacrolimus group:nothing;prednisone group:nothing;
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Primary Outcome(s)
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Proteinuria of 24 hour;
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Secondary Outcome(s)
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concentration of tacrolimus;remission rate;Recurrence rate;
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Source(s) of Monetary Support
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Chongqing Integrated Demonstration Project
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Ethics review
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Status: Approved
Approval date: 21/12/2017
Contact:
Fei Hao
023-68754814
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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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