BridgeMD
A trial to learn how well balcinrenone in combination with dapagliflozin works and how safe it is compared to dapagliflozin alone in adults with chronic kidney disease
EU CTIS ID: 2023-509709-63-00
What this study is testing
To determine whether balcinrenone in combination with dapagliflozin is superior to dapagliflozin in reducing albuminuria.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 18 years old
- 2.Diagnosis of CKD and eGFR ≥ 25 to < 60 mL/min/1.73 m2.
- 3. UACR > 100 mg/g (10 mg/mmol) to ≤ 5000 mg/g (500 mg/mmol).
- 4. Serum potassium ≥ 3.5 mmol/L to ≤ 5.0 mmol/L.
- 5. Stable RAAS inhibitors treatment for 4 weeks before screening. Participants who cannot tolerate or are not treated with RAAS inhibitors can also participate in the study.
You likely can't join if
- 1. Uncontrolled arterial hypertension (SBP > 160 mmHg or DBP > 100 mmHg).
- 7. Recent (90 d prior to screening) or ongoing dialysis, or likely need for dialysis within 3 months following randomization.
- 8. Acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to randomisation (Visit 2).
- 9. Type 1 diabetes mellitus (DM) or uncontrolled type 2 DM.
- 13. Any use of the following within 4 weeks prior to screening: - MRA (or planned initiation of MRA treatment), potassium sparing diuretic, potassium binders, fludrocortisone. - Strong or moderate CYP3A4 inducers or inhibitors prohibited at least 1 week prior to randomisation and during treatment
- 10. Hepatic disease, including active hepatitis, and/or hepatic impairment (Child-Pugh class B-C; or any of AST or ALT > 3 × ULN; or TBL > 2 × ULN.
See the full eligibility criteria
- 1. Age ≥ 18 years old
- 2.Diagnosis of CKD and eGFR ≥ 25 to < 60 mL/min/1.73 m2.
- 3. UACR > 100 mg/g (10 mg/mmol) to ≤ 5000 mg/g (500 mg/mmol).
- 4. Serum potassium ≥ 3.5 mmol/L to ≤ 5.0 mmol/L.
- 5. Stable RAAS inhibitors treatment for 4 weeks before screening. Participants who cannot tolerate or are not treated with RAAS inhibitors can also participate in the study.
- 1. Uncontrolled arterial hypertension (SBP > 160 mmHg or DBP > 100 mmHg).
- 7. Recent (90 d prior to screening) or ongoing dialysis, or likely need for dialysis within 3 months following randomization.
- 8. Acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to randomisation (Visit 2).
- 9. Type 1 diabetes mellitus (DM) or uncontrolled type 2 DM.
- 13. Any use of the following within 4 weeks prior to screening: - MRA (or planned initiation of MRA treatment), potassium sparing diuretic, potassium binders, fludrocortisone. - Strong or moderate CYP3A4 inducers or inhibitors prohibited at least 1 week prior to randomisation and during treatment
- 10. Hepatic disease, including active hepatitis, and/or hepatic impairment (Child-Pugh class B-C; or any of AST or ALT > 3 × ULN; or TBL > 2 × ULN.
- 11. Serum HCO3 < 18 mmol/L at screening.
- 12. Adrenal insufficiency (eg, Addison's disease, prolonged use of glucocorticoids).
- 2. Hypotension defined as SBP < 100 mmHg.
- 3. Diagnosis of lupus nephritis or antineutrophil cytoplasmic antibody-associated vasculitis. Other nephropathies that are unstable, or progress rapidly, or require cytotoxic or immunomodulatory therapy.
- 4. Cytotoxic or immunomodulatory therapy within 6 months prior to screening, or current, or planned within 6 months following randomization.
- 5. Diagnosis of autosomal dominant polycystic kidney disease
- 6. History of solid organ or bone marrow transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Taiwan
- Japan
- Vietnam
- Canada
- Malaysia
- Brazil
- Turkey
- United States
- China
- Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Taiwan; Japan; Vietnam; Canada; Malaysia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.