ClinicaliQ Trial Snapshot
- A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD) — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07624305.
- What is being tested: A fixed-dose combination of balcinrenone (a non-steroidal mineralocorticoid receptor antagonist) plus dapagliflozin (SGLT2 inhibitor) versus dapagliflozin alone in patients with CKD Stage 3b-4, evaluating efficacy, safety and tolerability.
- Patient eligibility overview: Adults with chronic kidney disease Stage 3b-4 (eGFR 15-44 mL/min/1.73m²), representing moderate-to-advanced renal impairment where treatment options are clinically limited.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to < 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.
Eligibility Snapshot
- : * Age ≥ 18 years * Diagnosis of CKD and at least one of the following: 1. eGFR ≥ 15 to < 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory). 2. eGFR ≥ 15 to < 30 mL/min/1.73 m2 and UACR < 30 mg/g (local or central laboratory UACR value). * Serum/plasma K+ ≤ 5.0 mmol/L * Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.