First interim results from the FINE-REAL study, a prospective, non-interventional, phase 4 study, reveal insights into the use of finerenone in routine clinical practice for patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The study, involving participants from multiple countries, aimed to evaluate the characteristics, treatment patterns, and safety of finerenone in a real-world setting. This pre-specified interim analysis, conducted one year after study initiation, with a median follow-up of 7 months, provides valuable data on the practical application of finerenone in managing CKD and T2D.
Study Design and Patient Population
The FINE-REAL study enrolled participants aged 18 years or older with a diagnosis of CKD associated with T2D, who were receiving finerenone (10 or 20 mg) according to local marketing authorization. The study excluded individuals involved in investigational trials or with contraindications per the finerenone label. Data was collected on demographic characteristics, disease history, concomitant medications, laboratory parameters (eGFR and UACR), adverse events, hyperkalemia, and diabetic retinopathy assessments.
Key Findings
Of the 556 participants enrolled, 504 were included in the full analysis set. The mean age was 66.1 years, and 60.7% were male. The median duration of T2D was 14.0 years. Baseline eGFR and UACR measurements were documented for 97.4% and 71.8% of participants, respectively. Most participants (93.7%) had an eGFR ≥ 25 mL/min/1.73 m². At baseline, 71.8% were receiving ACEis or ARBs, 76.8% were on statins, 47.8% were receiving insulin, 46.6% were on SGLT2 inhibitors, and 33.3% were receiving GLP-1 receptor agonists.
Treatment Patterns and Safety
Most participants (87.9%) initiated finerenone at a dose of 10 mg. Treatment was continued uninterrupted in 92.3% of participants. Finerenone treatment was interrupted in 5.4% of participants, with the most frequent reason being an adverse event. Permanent discontinuation occurred in only five participants, two of whom discontinued due to hyperkalemia.
TEAEs were reported in 21.8% of participants, with hyperkalemia/blood potassium increase being the most frequent (5.0%). Serious TEAEs were reported in 5.4% of participants. Hyperkalemia was reported in 5.0% of participants, with no cases leading to dialysis, hospitalization, or death. The cumulative incidence of hyperkalemia was 1.2%, 1.2%, and 4.1% at months 1, 3, and 6, respectively.
Diabetic Retinopathy
Diabetic retinopathy was reported in 12.3% of participants at baseline. Among participants with NPDR (6.4%), 2.6%, 1.2%, and 1.2% were diagnosed with mild, moderate, or severe disease, respectively.
Clinical Implications
The FINE-REAL study provides valuable real-world evidence on the use of finerenone in patients with CKD and T2D. The findings suggest that finerenone is being initiated across various clinical settings and populations, with treatment discontinuation and hyperkalemia occurrence being low, consistent with clinical trial data. The study also highlights the importance of UACR screening for early detection of CKD, aligning with guideline recommendations. These results support the integration of finerenone into routine clinical practice for managing CKD and T2D, particularly in patients at high risk of cardiovascular and kidney events.
Comparison with Previous Studies
Compared to the FIDELITY trial, FINE-REAL included a greater proportion of participants in the moderate KDIGO risk category and fewer participants in the high-risk category, suggesting that physicians are increasingly treating patients with earlier-stage CKD. The low rate of hyperkalemia observed in FINE-REAL is also noteworthy, especially when compared to steroidal MRAs, which have been associated with a higher risk of hyperkalemia in previous studies.
Future Directions
The ongoing FINE-REAL study will continue to provide valuable insights into the long-term safety and effectiveness of finerenone in real-world settings. Future analyses will focus on longitudinal data on eGFR and UACR, as well as the association of participant characteristics with TEAEs. As more participants are enrolled, it may be possible to analyze how finerenone initiation varies across different nations, particularly when more low- and middle-income countries are included. Moreover, FINE-REAL will likely provide information on the treatment of patients with multimorbidity, including cardiovascular comorbidities.
