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

BACKGROUND

To compare the efficacy of glucocorticoids in primary focal segmental glomerulosclerosis (pFSGS) patients with moderate proteinuria. Registered at http://www.chictr.org.cn/ , study No. ChiCTR-OPN-17012789.

METHODS

pFSGS patients with urine protein between 1.0 and 3.5 g/24 h were recruited from 2006 to 2016. No decline in urine protein > 50% was observed after 2 months of run-in angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (ACEI/ARB) treatment. Patients were assigned to study group (glucocorticoids with ACEI/ARB) or control group (ACEI/ARB without glucocorticoids). Variables including 24-h urinary protein, serum albumin and serum creatinine during the trial were recorded. Remission was defined as proteinuria < 0.3 g/24 h or declined > 50%, and our composite end point as > 30% decrease of eGFR or eGFR < 30 ml/min.

RESULTS

A total of 102 patients were enrolled (study group N = 52, control group N = 50), and the median follow-up time was 36 (12-117) months without significant difference between groups. During the 12-month follow-up, the remission rate was significantly higher in study group [73.1 vs 50.0% (P = 0.01)], and the initial median response time was 3 months in the study group while 6 in the control group. The end point was reached by 22.2% cases in study group, and 42.0% in control. The medium survival times were study group 72 months and control 57 (P = 0.03). Minor adverse reactions were observed in 10 patients (study group N = 8, control group N = 2).

CONCLUSIONS

Additional glucocorticoids therapy is more efficacious compared to ACEI/ARB alone in the treatment of patients with pFSGS and moderate proteinuria.