A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
Public ClinicalTrials.gov record NCT07624305. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared With Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Chronic Kidney Disease (Stage 3b and 4)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07624305
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,800 participants
Conditions and interventions
Conditions
Interventions
- Balcinrenone/dapagliflozin Drug
- Dapagliflozin Drug
- Placebo matching Dapagliflozin Drug
- Placebo matching balcinrenone/dapagliflozin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2026
- Primary completion
- Jun 30, 2030
- Completion
- Jun 30, 2030
- Last update posted
- Sep 23, 2026
2026 – 2030
United States locations
- U.S. sites
- 68
- U.S. states
- 23
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Huntsville | Alabama | 35805 | Not yet recruiting |
| Research Site | Surprise | Arizona | 85374 | Recruiting |
| Research Site | Tempe | Arizona | 85284 | Not yet recruiting |
| Research Site | Little Rock | Arkansas | 72205 | Not yet recruiting |
| Research Site | Concord | California | 94520 | Recruiting |
| Research Site | Daly City | California | 94015 | Not yet recruiting |
| Research Site | Fremont | California | 94538 | Not yet recruiting |
| Research Site | Huntington Park | California | 90255 | Not yet recruiting |
| Research Site | Lancaster | California | 93534 | Not yet recruiting |
| Research Site | Lynwood | California | 90262 | Not yet recruiting |
| Research Site | Northridge | California | 91324 | Not yet recruiting |
| Research Site | Palo Alto | California | 94304 | Not yet recruiting |
| Research Site | Pomona | California | 91768 | Not yet recruiting |
| Research Site | Riverside | California | 92506 | Not yet recruiting |
| Research Site | San Dimas | California | 91773 | Not yet recruiting |
| Research Site | Tarzana | California | 91356 | Not yet recruiting |
| Research Site | Washington D.C. | District of Columbia | 20422 | Not yet recruiting |
| Research Site | Boca Raton | Florida | 33487 | Not yet recruiting |
| Research Site | Fort Lauderdale | Florida | 33316 | Not yet recruiting |
| Research Site | Gainesville | Florida | 32608 | Not yet recruiting |
| Research Site | Hollywood | Florida | 33021 | Not yet recruiting |
| Research Site | Jacksonville Beach | Florida | 32250 | Not yet recruiting |
| Research Site | Lakeland | Florida | 33813 | Not yet recruiting |
| Research Site | Melbourne | Florida | 32901 | Suspended |
| Research Site | Orlando | Florida | 32806 | Not yet recruiting |
| Research Site | Port Charlotte | Florida | 33952 | Not yet recruiting |
| Research Site | Riverview | Florida | 33578 | Recruiting |
| Research Site | Weston | Florida | 33331 | Not yet recruiting |
| Research Site | Brunswick | Georgia | 31520 | Not yet recruiting |
| Research Site | East Point | Georgia | 30344 | Not yet recruiting |
| Research Site | Macon | Georgia | 31210 | Not yet recruiting |
| Research Site | Savannah | Georgia | 31406 | Recruiting |
| Research Site | Oak Brook | Illinois | 60523 | Not yet recruiting |
| Research Site | Rockford | Illinois | 61107 | Not yet recruiting |
| Research Site | Iowa City | Iowa | 52246 | Not yet recruiting |
| Research Site | Wichita | Kansas | 67214 | Not yet recruiting |
| Research Site | Louisville | Kentucky | 40205 | Recruiting |
| Research Site | Ann Arbor | Michigan | 48105 | Not yet recruiting |
| Research Site | Saint Joseph | Michigan | 49085 | Not yet recruiting |
| Research Site | Mankato | Minnesota | 56001 | Not yet recruiting |
| Research Site | Kansas City | Missouri | 64111 | Not yet recruiting |
| Research Site | Albuquerque | New Mexico | 87108 | Not yet recruiting |
| Research Site | Albany | New York | 12209 | Not yet recruiting |
| Research Site | Long Island City | New York | 11106 | Not yet recruiting |
| Research Site | The Bronx | New York | 10468 | Not yet recruiting |
| Research Site | Asheville | North Carolina | 28805 | Not yet recruiting |
| Research Site | Charlotte | North Carolina | 28287 | Recruiting |
| Research Site | Cincinnati | Ohio | 45212 | Not yet recruiting |
| Research Site | Cincinnati | Ohio | 45220 | Not yet recruiting |
| Research Site | Media | Pennsylvania | 19063 | Not yet recruiting |
| Research Site | Columbia | South Carolina | 29209 | Not yet recruiting |
| Research Site | Greenville | South Carolina | 29607 | Not yet recruiting |
| Research Site | Chattanooga | Tennessee | 37404 | Not yet recruiting |
| Research Site | Fort Worth | Texas | 76104 | Recruiting |
| Research Site | Houston | Texas | 77043 | Not yet recruiting |
| Research Site | Irving | Texas | 75063 | Not yet recruiting |
| Research Site | Lufkin | Texas | 75904 | Not yet recruiting |
| Research Site | McKinney | Texas | 75069 | Not yet recruiting |
| Research Site | Pasadena | Texas | 77504 | Recruiting |
| Research Site | San Antonio | Texas | 78204 | Not yet recruiting |
| Research Site | San Antonio | Texas | 78212 | Not yet recruiting |
| Research Site | Sherman | Texas | 75092 | Not yet recruiting |
| Research Site | Stephenville | Texas | 76401 | Recruiting |
| Research Site | Sugar Land | Texas | 77478 | Recruiting |
| Research Site | Arlington | Virginia | 22205 | Not yet recruiting |
| Research Site | Richmond | Virginia | 23249 | Not yet recruiting |
| Research Site | Salem | Virginia | 24153 | Withdrawn |
| Research Site | Woodbridge | Virginia | 22192 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 409 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07624305, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2026 · Synced Sep 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07624305 live on ClinicalTrials.gov.