Clinical trial for Renal Insufficiency, Chronic
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?
Balcinrenone/dapagliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for renal insufficiency, chronic.
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
- 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.
- 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
- Diagnosis of CKD and at least one of the following:
- 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
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
- T1DM, except:
See the full eligibility criteria
- Age ≥ 18 years
- Diagnosis of CKD and at least one of the following:
- 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
- T1DM, except:
- 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.
- Any use of the following medications and supplements:
- 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's taking place
- Huntsville, Alabama, United States
- Surprise, Arizona, United States
- Tempe, Arizona, United States
- Little Rock, Arkansas, United States
- Concord, California, United States
- Daly City, California, United States
- Fremont, California, United States
- Huntington Park, California, United States
- Lancaster, California, United States
- Lynwood, California, United States
- Northridge, California, United States
- Palo Alto, California, United States
- Pomona, California, United States
- Riverside, California, United States
- San Dimas, California, United States
- Tarzana, California, United States
- Washington D.C., District of Columbia, United States
- Boca Raton, Florida, United States
- Fort Lauderdale, Florida, United States
- Gainesville, Florida, United States
+ 354 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 - 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?
Study sites include Huntsville, Alabama, United States; Surprise, Arizona, United States; Tempe, Arizona, United States; Little Rock, Arkansas, United States; Concord, California, United States; Daly City, California, United States and 368 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 ClinicalTrials.gov; the study team decides eligibility.