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Clinical Trials in India / NCT07624305
Recruiting Phase 3

A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)

NCT07624305 · tracked via the Priya Life Science India tracker
Phase
Phase 3
Started
2026-09-01
Last updated
2026-09-24

Condition(s) studied

Renal Insufficiency, Chronic

Investigational drug(s) / intervention(s)

Balcinrenone/dapagliflozin →Dapagliflozin →Placebo matching DapagliflozinPlacebo matching balcinrenone/dapagliflozin

Balcinrenone/dapagliflozin: balcinrenone/dapagliflozin 15 mg/10 mg

Dapagliflozin: dapagliflozin 10 mg

Placebo matching Dapagliflozin: matching placebo for dapagliflozin 10 mg

Placebo matching balcinrenone/dapagliflozin: matching placebo for balcinrenone/dapagliflozin

Study summary

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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation * UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening. * SBP \> 180 mmHg or DBP \> 110 mmHg at screening. * SBP \< 90 mmHg at screening. * HbA1c \> 9% at screening * T1DM, except: 1. For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible. 2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion. * Autosomal dominant polycystic kidney disease. * Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening. * Severe hepatic impairment (Child-Pugh Class C). * Adrenal insufficiency. * Clinically significant acute kidney injury within 12 weeks prior to the screening. * New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening. * Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months) prior to screening. * Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation. * Any use of the following medications and supplements: 1. MRAs 2. Aldosterone analogues 3. Aldosterone synthase inhibitors 4. Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation. 5. Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation

Primary outcome measure(s)

Trial sites (478)

FacilityCityRegionStatus
Research Site Huntsville Alabama Not Yet Recruiting
Research Site Surprise Arizona Recruiting
Research Site Tempe Arizona Not Yet Recruiting
Research Site Little Rock Arkansas Not Yet Recruiting
Research Site Concord California Recruiting
Research Site Daly City California Not Yet Recruiting
Research Site Fremont California Not Yet Recruiting
Research Site Huntington Park California Not Yet Recruiting
Research Site Lancaster California Not Yet Recruiting
Research Site Lynwood California Not Yet Recruiting
Research Site Northridge California Not Yet Recruiting
Research Site Palo Alto California Not Yet Recruiting
Research Site Pomona California Not Yet Recruiting
Research Site Riverside California Not Yet Recruiting
Research Site San Dimas California Not Yet Recruiting
Research Site Tarzana California Not Yet Recruiting
Research Site Washington D.C. District of Columbia Not Yet Recruiting
Research Site Boca Raton Florida Not Yet Recruiting
Research Site Fort Lauderdale Florida Not Yet Recruiting
Research Site Gainesville Florida Not Yet Recruiting
Research Site Hollywood Florida Not Yet Recruiting
Research Site Jacksonville Beach Florida Not Yet Recruiting
Research Site Lakeland Florida Not Yet Recruiting
Research Site Melbourne Florida Suspended
Research Site Orlando Florida Not Yet Recruiting
Research Site Port Charlotte Florida Not Yet Recruiting
Research Site Riverview Florida Recruiting
Research Site Weston Florida Not Yet Recruiting
Research Site Brunswick Georgia Not Yet Recruiting
Research Site East Point Georgia Not Yet Recruiting
Research Site Macon Georgia Not Yet Recruiting
Research Site Savannah Georgia Recruiting
Research Site Oak Brook Illinois Not Yet Recruiting
Research Site Rockford Illinois Not Yet Recruiting
Research Site Iowa City Iowa Not Yet Recruiting
Research Site Wichita Kansas Not Yet Recruiting
Research Site Louisville Kentucky Recruiting
Research Site Ann Arbor Michigan Not Yet Recruiting
Research Site Saint Joseph Michigan Not Yet Recruiting
Research Site Mankato Minnesota Not Yet Recruiting

+ 438 more sites — see the full list on the official registry below.

On this site

📄 Farxiga (dapagliflozin) drug profile →

More AstraZeneca trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07624305 on ClinicalTrials.gov ↗ ← All trials in India