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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.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-ONC-12002809
Date of registration: 2012-05-24
Prospective Registration: No
Primary sponsor: The First Affiliated Hospital of Dalian Medical University
Public title: Clinical Study of Prediction of Glucocorticoid Efficacy by cytokins in Patients with Primary Nephrotic Syndrome
Scientific title: Clinical Study of Prediction of Glucocorticoid Efficacy by cytokins in Patients with Primary Nephrotic Syndrome
Date of first enrolment: 2009-01-01
Target sample size: 1:90;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=6745
Study type:  Observational study
Study design:  historical control  
Phase:  Other
Countries of recruitment
China
Contacts
Name: Lin Hong-li   
Address:  222 Zhongshan Road, Dalian
Telephone: +86 13332268576
Email: linhongli@vip.163.com
Affiliation:  The First Affiliated Hospital of Dalian Medical University
Name: Xie Hua   
Address:  222 Zhongshan Road, Dalian
Telephone: +86 15541191277
Email: wlciq007@163.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: (1) >=18years old;
(2) Primary nephrotic syndrome and no application of glucocorticoid or immunosuppressive agents;
(3) Blood pressure can effectively control less than 130/80mmHg or without hypertension;
(4) Taking an ARB or ACEI drugs more than four weeks;
(5) Serum creatinine level <=200umol/L;
(6) Routine renal biopsy.

Exclusion criteria: (1) All kinds of secondary nephrotic syndrome, such as lupus nephritis, Henoch-Schonlein purpura nephritis, diabetic nephropathy, hypertensive nephropathy and so on;
(2) BMI between <=18 or >=25;
(3) Urine protein quantitative maitains 0.3-3g/24h after prescription with glucocorticoid 8 weeks;
(4) The patients participating the other trials;
(5) Researchers consider the patients not suitable for clinical trials.


Age minimum: 18
Age maximum: 75
Gender: Both
Health Condition(s) or Problem(s) studied
Idiopathic nephrotic syndrome
Intervention(s)
1:Given methylprednisolone according to the status of the patients ;
Primary Outcome(s)
Cytokines Level;
Secondary Outcome(s)
Cumulative remission;Serum creatinine;eGFR;Serum albumin;24h Urine protein quantity;
Secondary ID(s)
Source(s) of Monetary Support
Grant from the National Basic Research Program of China (No. 2011CB944000).
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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