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Safety and efficacy of dapagliflozin in patients with focal segmental glomerulosclerosis: A prespecified analysis of the DAPA-CKD trial. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association Wheeler, D. C., Jongs, N., Stefansson, B. V., Chertow, G. M., Greene, T., Hou, F. F., Langkilde, A. M., McMurray, J. J., Rossing, P., Nowicki, M., Wittmann, I., Correa-Rotter, R., Sjostrom, C. D., Toto, R. D., Heerspink, H. J., DAPA-CKD Trial Committees and Investigators 2021

Abstract

BACKGROUND: Despite renin-angiotensin-aldosterone-system blockade and immunosuppressive treatment, focal segmental glomerulosclerosis (FSGS) often progresses to kidney failure. The objective of this pre-specified analysis of DAPA-CKD was to assess efficacy and safety of dapagliflozin in a small subgroup participants with FSGS confirmed by kidney biopsy.METHODS: In DAPA-CKD, patients with estimated glomerular filtration rate (eGFR) 25-75mL/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) 200-5000mg/g (22.6-565mg/mol) were randomised to dapagliflozin 10mgonce-daily or placebo as an adjunct to standard care, and followed for median 2.4 years. The primary composite endpoint was sustained eGFR decline=50%, end-stage kidney disease (ESKD), or kidney or cardiovascular death. The endpoint of interest for this analysis was eGFR slope (acute effects from baseline to Week 2 and chronic effects from Week 2 to end of treatment).RESULTS: Of 104 participants with biopsy-confirmed FSGS, 45 were randomised to dapagliflozin and 59 to placebo. Mean (SD) age was 54.0 (14.3) years, mean eGFR 41.9 (11.5) mL/min/1.73m2 and median (IQR) UACR 1248 (749-2211) mg/g. The primary outcome occurred in 4 (8.9%) and 7 (11.9%) participants randomised to dapagliflozin and placebo, respectively (HR 0.62, 95%CI 0.17-2.17). Dapagliflozin led to a larger acute reduction (SE) in eGFR compared to placebo (-4.5 [95% CI-5.9--3.1] vs-0.9 [-2.1-0.4] mL/min/1.73m2 per 2 wks). Thereafter, mean rates of chronic eGFR decline with dapagliflozin and placebo were-1.9 (-3.0--0.9) and-4.0 (-4.9--3.0) mL/min/1.73m2/year, respectively (difference 2.0 [95%CI 0.6-3.5] mL/min/1.73m2/year). Adverse events leading to study drug discontinuation were similar in both groups; there were fewer serious adverse events with dapagliflozin.CONCLUSION: Among DAPA-CKD participants with FSGS, dapagliflozin reduced the rate of chronic decline of eGFR compared to placebo, although this difference was not statistically significant.

View details for DOI 10.1093/ndt/gfab335

View details for PubMedID 34850160