Renal Outcomes in FIDELIO-DKD Trial in Subset of Black Patients

NKF 2021 Spring Clinical Meetings

More than one third of patients in the United States receiving dialysis are Black or African American. The leading cause of kidney failure in that patient population is diabetes. Results of the FIDELIO-DKD trial of finerenone demonstrated a reduction in risk of progression of chronic kidney disease in patients with CKD and type 2 diabetes treated with finerenone.

During a virtual poster session at the NKF Spring Clinical Meetings 2021, George Bakris, MD, and colleagues reported results of an analysis of data from FIDELIO-DKD on outcomes among Black or African American patients. The poster was titled Impact of Finerenone on Chronic Kidney Disease Progression in Black or African American Patients with Type 2 Diabetes—Analysis of the FIDELIO-DKD Study.

The study randomized 5734 patients from 48 countries to receive either oral finerenone or placebo. Inclusion criteria were type 2 diabetes, urine albumin-creatinine ratio (UACR) 30-5000 mg/g, estimated glomerular filtration rate (eGFR) 25-<75 mL/min/1.73 m², and treatment with optimized renin-angiotensin system blockade. The primary renal outcomes of interest was time to kidney failure, sustained decline in eGFR ≥40% from baseline, or renal death. Prespecified secondary outcomes were time to kidney failure, sustained eGFR decline 57% from baseline or renal death, and change in UACR from baseline to month 4.

Of the overall cohort, 4.7% (n=264) were Black or African American. Of those, 76.5% were from North America. Median follow-up was 2.6 years.

Compared with White or Asian patients, the risk of kidney failure outcomes was higher in Black patients. In the subgroup of Black patients, the incidence rate of the primary kidney outcome was lower in the finerenone group than in the placebo group (13.9/100 patient years vs 17.2/100 patient years; hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.51-1.19, respectively). The incidence rate for the secondary kidney outcome was also lower in Black patients in the finerenone group compared with the placebo group (HR, 0.76; 95% CI, 0.45-1.28). At month 4, UACR was reduced by 33% (95% CI, 43%-21%) in Black patients treated with finerenone compared with placebo.

There was no evidence of heterogeneity between Black or African American patients and other racial/ethnic groups for the kidney outcomes analyzed. In the subgroup of Black or African American patients, treatment-emergent adverse events and serious adverse events were balanced between the finerenone group and the placebo group.

In conclusion, the researchers said, “In FIDELIO-DKD there was a trend toward reducing kidney outcomes in the small subset of Black patients included in the trial.”

Source: Bakris G, Joseph A, Anker S, et al. Impact of finerenone on chronic kidney disease progression in Black or African American patients with type 2 diabetes—analysis of the FIDELIO-DKD study. Abstract of a poster presented at the National Kidney Foundation virtual Spring Clinical Meetings 2021 (Abstract #254), April 9, 2021. FIDELIO-DKD was funded by Bayer AG (NCT02540993).