A phase 3 study of finerenone in nondiabetic chronic kidney disease

Below is a summary of “Design and baseline characteristics of the randomized Finerenone trial for the progression of kidney disease in patients with nondiabetic chronic kidney disease (FIND-CKD) in addition to standard of care,” published in the June 2024 issue of Nephrology by Heerspink et al.

Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, improved renal and cardiovascular outcomes in people with chronic kidney disease (CKD) and type 2 diabetes (T2D).

Researchers conducted a prospective study in nondiabetic chronic kidney disease (FIND-CKD) to determine whether finerenone provides similar benefits for adults with CKD who do not have diabetes.

They conducted a Phase 3 trial in adults with non-diabetic CKD. Patients received either a daily dose of placebo or finerenone (10 or 20 mg) based on their eGFR values ​​(≤ 60 ml/min/1.73 m² or higher) and urinary albumin-to-creatinine ratio (UACR, ≥200 to ≤3500 mg/g). The primary objective was to track eGFR changes over 32 months, with secondary objectives including safety of cardiorenal outcomes, sustained eGFR decline of ≥57%, hospitalizations for heart failure (HF) or cardiovascular death (CVD), and separate combined renal and cardiovascular outcomes.

The results showed 3,231 patients in 24 countries, of whom 1,584 were randomized to the study. Most had chronic glomerulonephritis (57%) or hypertensive/ischemic nephropathy (29%). The most common glomerulonephritis was immunoglobulin A nephropathy (26.3% of the population). The average eGFR was 46.7 ml/min/1.73 m² and median UACR 818.9 mg/g. Diuretics, statins, and calcium channel blockers were used by 17.8% (n=282), 53.7% (n=851), and 50.1% (n=794) of patients, respectively. Sodium-glucose cotransporter 2 (SGLT2) inhibitors were used by 16.9%, with a similar eGFR (45.6 vs. 46.8) and a slightly higher UACR (871.9 vs. 808.3 mg/g) compared with no use of SGLT2 inhibitors at baseline.

The researchers concluded that FIND-CKD was the first Phase 3 trial to test finerenone in patients with non-diabetic CKD.

Source: academic.oup.com/ndt/advance-article/doi/10.1093/ndt/gfae132/7690802