Results from a Phase 2 trial evaluating a combination of balcinrenone/dapagliflozin against dapagliflozin alone in adults with chronic kidney disease (CKD) were posted on 2026-06-26. The study found that the higher dose of the combination therapy led to a 32.77% greater reduction in urinary albumin-to-creatinine ratio (UACR) compared to dapagliflozin alone.
Background
This study aimed to evaluate the efficacy, safety, and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone in patients diagnosed with chronic kidney disease and albuminuria. The primary objective was to assess the effect of the combination therapy on UACR, a key indicator of kidney function and damage.
Trial design
This was a Phase 2, dose-finding study (NCT06350123) that enrolled 324 adult participants with chronic kidney disease. The trial compared two doses of the combination therapy, balcinrenone/dapagliflozin 15 mg/10 mg and balcinrenone/dapagliflozin 40 mg/10 mg, against a control arm of dapagliflozin 10 mg. The study's main goal was to identify an optimal dose of the combination for potential future Phase 3 development in patients with CKD.
Key results
The trial measured the relative change in Urine Albumin-to-Creatinine Ratio (UACR) from baseline to Week 12. The geometric least squares mean for UACR relative change was 0.76 mg/g for the balcinrenone/dapagliflozin 15 mg/10 mg group, 0.66 mg/g for the balcinrenone/dapagliflozin 40 mg/10 mg group, and 0.98 mg/g for the dapagliflozin 10 mg group.
Key analyses showed significant differences in percent change in UACR:
- The balcinrenone/dapagliflozin 40 mg/10 mg group demonstrated a -32.77% (90% Confidence Interval: -41.96 to -22.14) greater reduction in UACR compared to dapagliflozin 10 mg, with a p-value of 0.001.
- The balcinrenone/dapagliflozin 15 mg/10 mg group showed a -22.83% (90% Confidence Interval: -33.34 to -10.66) greater reduction in UACR compared to dapagliflozin 10 mg, with a p-value of 0.0038.
What this means
The results indicate that both doses of the balcinrenone/dapagliflozin combination therapy achieved a statistically significant and greater reduction in UACR compared to dapagliflozin alone in patients with chronic kidney disease. The higher dose of balcinrenone/dapagliflozin 40 mg/10 mg showed the most pronounced effect. These findings support the potential of this combination therapy for managing CKD and provide crucial data for selecting an optimal dose for further investigation in a Phase 3 study.
Source
The trial results were posted on 2026-06-26 on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT06350123.