balcinrenone/​dapagliflozin / AstraZeneca - LARVOL DELTA

Efficacy and Safety of Balcinrenone in Combination with Dapagliflozin on Albuminuria in Participants with CKD (KIDNEY WEEK 2025) - P2 | "Funding Commercial Support – AstraZeneca Background SGLT2is reduce albuminuria and the risk of CKD progression, and the MRA finerenone has similar effects in T2D with CKD...Methods In this double-blind, active-controlled clinical trial (NCT06350123), adults with eGFR of 25–100–5000 mg/g, and potassium 3.5–5.0 mmol/L, were randomized 1:1:1 to combined balcinrenone/dapagliflozin 15/10 mg, balcinrenone/dapagliflozin 40/10 mg, or placebo/dapagliflozin 10 mg as adjunct to RAS inhibitors for 12 weeks, followed by an 8-week wash-out period...Conclusion In participants with CKD, combined balcinrenone and dapagliflozin was superior to dapagliflozin in reducing albuminuria. The combination was well-tolerated with minor effects on potassium."

Clinical • Combination therapy • Late-breaking abstract • Chronic Kidney Disease • Renal Disease

BalanceD-HF - A phase 3 Study To Evaluate The Effect Of Balcinrenone/dapagliflozin In Patients With Heart Failure And Impaired Kidney Function (NCT06307652) (HFSA 2025) - P3 | "Suspected HF events and the causes of deaths are adjudicated by a blinded Clinical Endpoint Committee. An independent Data Monitoring Committee is monitoring safety data on a regular basis.BalanceD-HF is a unique trial that is evaluating a novel MR modulator (balcinrenone) combined with an SGLT2i (dapagliflozin) in the understudied population of patients with HF (across the LVEF spectrum) and impaired kidney function."

Clinical • P3 data • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Nephrology • Renal Disease

A Study to Investigate the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants. (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion

Efficacy and safety of balcinrenone and dapagliflozin for CKD: design and baseline characteristics of the MIRO-CKD trial. (PubMed, Nephrol Dial Transplant) - "MIRO-CKD is a fully recruited global trial enrolling a contemporary CKD population at increased risk of progression and with an increased risk of hyperkalaemia based on their reduced kidney function. The study will assess the efficacy, safety and tolerability of the combination of balcinrenone and dapagliflozin to identify an optimal dose for a future phase 3 study in patients with CKD."

Journal • Cardiovascular • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Design and baseline characteristics of MIRO-CKD: a Phase IIb, Randomised, Double-Blind Clinical Trial to Evaluate Effects of Balcinrenone in Combination with Dapagliflozin vs. Dapagliflozin in Patients with CKD (ERA 2025) - P2 | " MIRO-CKD is a phase IIb, international, randomised, double-blind, parallel-group trial in adults with CKD (estimated glomerular filtration rate [eGFR] ≥25 to 100 to ≤5000 mg/g) and potassium ≥3.5 to ≤5mmol/L (NCT06350123), where participants have been randomised 1:1:1 to three treatment arms: balcinrenone/dapagliflozin 15 mg/10 mg, balcinrenone/dapagliflozin 40 mg/10 mg or placebo/dapagliflozin 10 mg for 12 weeks followed by an 8-week wash-out period to assess off-drug effects. MIRO-CKD is a fully recruited global phase IIb trial enrolling a contemporary CKD population at increased risk of disease progression and with an increased risk of hyperkalaemia based on their reduced kidney function. The study will assess the efficacy, safety and tolerability of the combination of balcinrenone and dapagliflozin with the aim to identify an optimal dose for a future phase III study in patients with CKD."

Clinical • Combination therapy • P2b data • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Type 2 Diabetes Mellitus

A Study to Investigate the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants. (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants. (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

MIRO-CKD: Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=324 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

BalanceD-HF: Phase III study to evaluate the effect of balcinrenone/dapagliflozin in patients with heart failure and impaired kidney function (ChiCTR) - P3 | N=4800 | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P3 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

A Phase I PK Study of Balcinrenone/Dapagliflozin in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: AstraZeneca | Not yet recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Oct 2024 | Trial primary completion date: Apr 2025 ➔ Oct 2024

Trial completion • Trial completion date • Trial primary completion date

MIRO-CKD: Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=324 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ May 2025 | Trial primary completion date: Jan 2026 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

Balcinrenone/dapagliflozin in patients with heart failure and impaired kidney function – the Phase 3 BalanceD-HF study design (NCT06307652) (CVCT USA 2024) - P3 | No abstract available

Clinical • P3 data • Cardiovascular • Congestive Heart Failure • Heart Failure

A Phase 2b Dose-Finding Study to Evaluate Effects of Balcinrenone/Dapagliflozin vs. Dapagliflozin in Patients with CKD and Albuminuria (KIDNEY WEEK 2024) - P2, P2b | "Funding. Commercial Support – AstraZeneca ."

Clinical • P2b data • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Hypotension • Nephrology • Renal Disease

A Phase I PK Study of Balcinrenone/Dapagliflozin in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

Design Of BalanceD-HF - A Phase 3 Study To Evaluate The Effect Of Balcinrenone/Dapagliflozin In Patients With Heart Failure And Impaired Kidney Function (NCT06307652) (HFSA 2024) - P3 | "An independent Data Monitoring Committee is monitoring safety data on a regular basis. BalanceD-HF is a unique trial that is evaluating a novel MR modulator (balcinrenone) combined with an SGLT2i (dapagliflozin) in the understudied population of patients with HF (across the LVEF spectrum) and impaired kidney function."

Clinical • P3 data • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Nephrology • Renal Disease