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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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16 December 2019 |
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Main ID: |
ChiCTR1900026883 |
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Date of registration:
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2019-10-25 |
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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 prospective randomized controlled trial of a new method for glucocorticoid intervention in progressive IgA nephropathy
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Scientific title:
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A prospective randomized controlled trial of a new method for glucocorticoid intervention in progressive IgA nephropathy |
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Date of first enrolment:
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2019-12-01 |
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Target sample size:
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1:71;2:71; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=42829 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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0
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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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Bin Zhu
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Address:
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453 Stadium Road, Hangzhou, Zhejiang
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Telephone:
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+86 15888826243 |
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Email:
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zhubing@hotmail.com |
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Affiliation:
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Nephrology Department, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang |
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Name:
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Bin Zhu
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Address:
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453 Stadium Road, Hangzhou, Zhejiang
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Telephone:
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+86 15888826243 |
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Email:
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zhubing@hotmail.com |
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Affiliation:
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Nephrology Department, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Renal biopsy confirmed IgAN patients;
2. Aged 18-72 years, gender is not limited;
3. After the maximum tolerated dose of RAS blocker (addition of other antihypertensive drugs when not ineffective), the urine protein (most recently examined) after treatment is between 1.0g and 3.5g/day;
4. eGFR (last inspection): 30 - 120ml/min·1.73m2 (inclusive).
Exclusion criteria: 1. Indications for the use of intensive glucocorticoids for immunosuppressive therapy, such as: nephrotic syndrome with minimal pathology and IgAN, and a proportion of crescents confirmed by renal biopsy within 12 months >50%;
2. Contraindications for immunosuppressive therapy using glucocorticoids, including infections, tuberculosis, malignant tumors, pregnant and lactating patients, etc.;
3. Received immunosuppressive therapy in the past 1 year;
4. Malignant or uncontrolled hypertension (systolic blood pressure > 160mm or diastolic blood pressure > 110mmHg);
5. Have clear secondary causes, such as autoimmune diseases, cirrhosis and other secondary IgA nephropathy;
6. Poor compliance, not with treatment;
7. Participate in other clinical studies (involved or participated in the previous month).
Age minimum:
18
Age maximum:
72
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IgA nephropathy
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Intervention(s)
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1:0.5mg/kg.d prednisolone induced remission;2:0.8mg/kg.d prednisolone induced remission ;
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Primary Outcome(s)
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Reduction of eGFR>40%, renal replacement therapy, ESRD;
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Secondary Outcome(s)
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Glomerular filtration rate;Urinary protein creatinine ratio;24h urine protein quantitation;Blood uric acid;
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Source(s) of Monetary Support
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Zhejiang Natural Science Foundation Committee Item No.: LGF18H050005
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Ethics review
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Status: Approved
Approval date:
Contact:
Lai Zhang
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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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