|
Main
|
|
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-TQR-12002602 |
|
Date of registration:
|
2012-10-16 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Effects of an Combinedative Treatment of with Prednisone plus and Fluvastatin on the Levels of Cholesterol and Bilirubin in the Patients with Minimal Change Nephropathy
|
|
Scientific title:
|
The Effects of an Combinedative Treatment of with Prednisone plus and Fluvastatin on the Levels of Cholesterol and Bilirubin in the Patients with Minimal Change Nephropathy |
|
Date of first enrolment:
|
2009-10-09 |
|
Target sample size:
|
Treatment:30;Control:30; |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=6949 |
|
Study type:
|
Interventional study |
|
Study design:
|
Quasi-randomized controlled
|
|
Phase:
|
I (Phase I study)
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Minghui Song
|
|
Address:
|
4 West Beach Road, Beidaihe District, Qinhuangdao, Hebei, China
|
|
Telephone:
|
+86 13930300051 |
|
Email:
|
mhso1@sina.com |
|
Affiliation:
|
|
|
|
Name:
|
Minghui Song
|
|
Address:
|
4 West Beach Road, Beidaihe District, Qinhuangdao, Hebei, China
|
|
Telephone:
|
+86 13930300051 |
|
Email:
|
mhso1@sina.com |
|
Affiliation:
|
Treatment center of kidney disease, 281th hospital of PLA |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Morphologically normal light microscope glomerular see the swelling of the renal tubular epithelial cells within lipid deposition, electron microscope, epithelial cell swelling, foot processes are widely fusion flattened basement membrane normal. Immunology positive findings. The the Clinical Changbiaoxianwei typical nephrotic syndrome, urinary protein levels greater than 3.5g/24h; plasma albumin content of less than 30g/L, a high degree of swelling, and hyperlipidemia.
Exclusion criteria: Patients with secondary renal disease, or/and glucocorticoid resistance were excluded.
Age minimum:
4
Age maximum:
12
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Minimal change nephrotic syndrome in children
|
|
Intervention(s)
|
|
Treatment:prednisone 1~2 mg/kg/day+Fluvastatin Sodium Capsule;Control:prednisone 1~2 mg/kg/day;
|
|
Primary Outcome(s)
|
|
TCHO, TG, TBil, Dbil, ALB ;
|
|
Secondary Outcome(s)
|
|
Renal biopsy puncture;
|
|
Source(s) of Monetary Support
|
|
Hospital funded
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|