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
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosis of CKD and at least one of the following:
1. 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).
2. 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.
Exclusion Criteria:
* 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:
1. 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.
2. 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:
1. MRAs
2. Aldosterone analogues
3. Aldosterone synthase inhibitors
4. Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation.
5. Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation
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.
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.
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