Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.
Timeline
- Start
- 2024-05-01
- Primary completion
- 2025-05-09
- Completion
- 2025-05-09
Outcome
Met primary endpoint
registry analysis (superiority test); Balcinrenone/Dapagliflozin 40 mg/10 mg vs Dapagliflozin 10 mg; p <0.001; Percent change difference -32.77 (90% CI -41.96 to -22.14); Mixed Models Analysis NCT06350123 ↗
registry analysis (superiority test); Balcinrenone/Dapagliflozin 15 mg/10 mg vs Dapagliflozin 10 mg; p = 0.0038; Percent Change Difference -22.83 (90% CI -33.34 to -10.66); Mixed Models Analysis NCT06350123 ↗
Publications
- Heerspink HJL, Cardona JF, Jolly S, Pergola PE, de Sousa-Amorim E, Eriksson AL, Fredholm M, Gasparyan SB, Guzman NJ, Hartleib-Geschwindner J, Jiang Y, Leonsson-Zachrisson M, Mark PB; MIRO-CKD study investigators. Balcinrenone in combination with dapagliflozin compared with dapagliflozin alone in patients with chronic kidney disease and albuminuria: a randomised, active-controlled double-blind, phase 2b clinical trial. Lancet. 2025 Nov 22;406(10518):2449-2460. doi: 10.1016/S0140-6736(25)02014-8. Epub 2025 Nov 8.
- Mark PB, De Sousa-Amorim E, Eriksson AL, Leonsson-Zachrisson M, Guzman NJ, Miller MT, Jiang Y, Heerspink HJL. Efficacy and safety of balcinrenone and dapagliflozin for CKD: design and baseline characteristics of the MIRO-CKD trial. Nephrol Dial Transplant. 2025 Nov 26;40(12):2280-2288. doi: 10.1093/ndt/gfaf119.
- Bhattacharya CS, Ericsson H, Johansson S, Parkinson J, Boca SM, Yang Y, Heijer M, Housler G, Leonsson-Zachrisson M, Hartleib-Geschwindner J, Pizzato PE. The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of balcinrenone. Br J Clin Pharmacol. 2025 Jul;91(7):1937-1946. doi: 10.1002/bcp.70017. Epub 2025 Feb 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balcinrenone | Small molecule | 15 mg | Oral |
| Subject | Balcinrenone | Small molecule | 40 mg | Oral |
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |