Glucocorticoids in the treatment of patients with primary focal segmental glomerulosclerosis and moderate proteinuria

• Register: ChiCTR
• Last refreshed on: 2 October 2017
• Main ID: ChiCTR-OPN-17012789
• Date of registration: 2017-09-25
• Prospective Registration: No
• Primary sponsor: Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
• Public title: Glucocorticoids in the treatment of patients with primary focal segmental glomerulosclerosis and moderate proteinuria
• Scientific title: Glucocorticoids in the treatment of patients with primary focal segmental glomerulosclerosis and moderate proteinuria
• Date of first enrolment: 2006-06-01
• Target sample size: study group:52;control group:50;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=21827
• Study type: Observational study
• Study design: Non randomized control
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Nan Chen
• Affiliation: Nephrology Department, Ruijin Hospital, Shanghai Jiaotong university affiliated Ruijin Hospital

• Name: Hong Ren
• Affiliation: Nephrology Department, Ruijin Hospital, Shanghai Jiaotong university affiliated Ruijin Hospital

Key inclusion & exclusion criteria

Inclusion criteria: FSGS patients were recruited in the Department of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University from 2006 to 2016. The following qualifiers have to be fulfilled prior to the recruitment:
(1) Aged between 17 and 80 years;
(2) Renal biopsy was acquired;
(3) EPI-eGFR=30 ml/min/1.73 m2;
(4) 24-hour urine protein is between 1.0g-3.5g for equal to or more than twice;
(5) Serum albumin>25g/L;
(6) no remarkable decline in urine protein was observed after at least 1 month of ACEI/ARB drugs treatment;
(7) no usage of glucocorticoids within 3 months prior to the study;
(8) Signed informed consent.
Exclusion criteria: Patients with the following features were excluded:
(1) secondary FSGS;
(2) family history of kidney diseases;
(3) hepatitis virus carrier, chronic viral hepatitis or abnormal liver function;
(4) any active or serious infection;
(5) unwilling to adhere to the study protocol.

Age minimum: 17
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

focal segmental glomerulosclerosis

Intervention(s)

study group:prednisone treatment;control group:ACEI/ARB;

Primary Outcome(s)

24h protein urine;serum albumin;creatinin;

Source(s) of Monetary Support

National Key Research and Development Program of China (2016YFC0904100), the National Natural Science Foundation of China (No. 81570598), and Shanghai Natural Science Foundation (15ZR1426300)