Renal Insufficiency, Chronic study: Balcinrenone/dapagliflozin vs Dapagliflozin
Official title A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
ClinicalTrials.gov ID: NCT07624305
What this study is testing
What is Balcinrenone/dapagliflozin?
This is an investigational pill being studied to see if it helps slow the worsening of chronic kidney disease. It is designed to work by combining a medicine that blocks a hormone called aldosterone with a medicine that helps the kidneys remove extra salt and water.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding balcinrenone to dapagliflozin works better than dapagliflozin alone. It also checks how safe the new mix is and what side effects it causes.
- Who it's for
- You may be able to join if you have stage 3b or 4 chronic kidney disease.
- What's involved
- You would take a pill once a day. You would also get your usual care for your kidney condition.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Age ≥ 18 years
- 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...
- 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.
You likely can't join if
- 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
- 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...
See the full eligibility criteria
- Age ≥ 18 years
- 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).
- 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.
- 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
- 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.
- 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.
- MRAs
- Aldosterone analogues
- Aldosterone synthase inhibitors
- Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation.
- Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation
The study team makes the final eligibility decision.
Where it is enrolling
- Surprise, Arizona, United States
- Concord, California, United States
- Riverview, Florida, United States
- Savannah, Georgia, United States
- Louisville, Kentucky, United States
- Charlotte, North Carolina, United States
- Fort Worth, Texas, United States
- Pasadena, Texas, United States
- Stephenville, Texas, United States
- Sugar Land, Texas, United States
- Waterloo, Ontario, Canada
- Ageo, Japan
- Asahi-shi, Japan
- Kariya, Japan
- Kita-ku, Japan
- Koga-shi, Japan
- Koshigaya-shi, Japan
- Kumamoto, Japan
- Kuwana-shi, Japan
- Minokamo Shi, Japan
+ 12 more site(s).
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, but 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 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Surprise, Arizona, United States; Concord, California, United States; Riverview, Florida, United States; Savannah, Georgia, United States; Louisville, Kentucky, United States; Charlotte, North Carolina, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.