A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure, sustained 50% or greater decline in eGFR, and heart failure event — Up to 46 months.
Time from randomization to first occurrence of any of the components of the composite: * CV death * Death from kidney failure * Onset of kidney failure * Initiation of maintenance dialysis or * Kidney transplantation * Sustained ≥ 50% decline from baseline in eGFR * HF with or without hospitalisation
Trial sites (478)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 France
Other trials for the same condition
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 France