Phase
Condition
N/ATreatment
Dapagliflozin matching Placebo
Balcinrenone 50mg matching Placebo
Balcinrenone 100mg Capsule
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of chronic kidney disease, with eGFR ≥30 and ≤60 mL/min/1.73m2
Serum/ plasma K+ levels ≥ 3.5 and < 5.0 mmol/L OR within normal laboratory rangeswhen these are provided, within 2 weeks prior to randomization
Serum/plasma Na+ levels within normal reference values within 2 weeks prior torandomization
If participants have type 2 diabetes mellitus, treatment with metformin,sulphonylureas, DPP4 inhibitors or any combinations of these agents with or withoutinsulin would be accepted but is not mandatory. If used, stable dose of metformin,sulphonylureas, or DPP4 inhibitors or their combination as anti-diabetic therapy forthe 12 weeks prior to randomization is required
No changes in background treatment for at least 3 weeks prior to randomization
Body mass index less than 40 kg/m2
Negative pregnancy test (urine or serum) for female subjects of childbearingpotential and willingness to use a highly effective birth control (see Appendix 4)if of childbearing potential.
Willingness to participate and ability to provide signed informed consent asdescribed in Appendix 1 which includes compliance with the requirements andrestrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion
Exclusion Criteria:
Diagnosis of type 1 diabetes mellitus
Uncontrolled type 2 diabetes mellitus with HbA1C > 10.5% in the most recent medicalrecords
Participants with type 2 diabetes mellitus treated with insulin if insulin dosing (intermediate, long-acting, premixed insulin, basal bolus insulin) was not stable inthe 12 weeks prior to randomization as judged by the Investigator
Patients with systolic blood pressure levels <100 mmHg at the time of enrolment
Patients with congestive heart failure NYHA stage IV or hospitalized fordecompensation of heart failure in the 3 months prior to screening
History of any life-threatening cardiac arrhythmias, or uncontrolled ventricularrate in participants with atrial fibrillation or atrial flutter
Acute coronary syndrome and/or percutaneous cardiac interventions within 3 monthsprior to screening
Unstable or rapidly progressing renal disease
Chronic cystitis and recurrent genital or urinary tract infections
Significant hepatic disease, including hepatitis and/or liver cirrhosis (Child-Pughclass A-C), or AST or ALT > 2 × ULN (upper limit of normal); or total bilirubinlevels (TBL) > 2 × ULN; or serum albumin levels < 3.5 g/dL
Medical conditions associated with development of hyperkalemia (Addison's disease)
Stroke, transient ischemic attack, carotid surgery, or carotid angioplasty within 3months prior to screening
Hemoglobin levels below 8.5 g/dL or over 15 g/dL OR over the normal laboratoryranges, when these are provided
Patients who have received an organ transplant at any time or bone marrow transplantin the previous 10 years
HIV infection
Active cancer, history of bladder cancer
Patients who have had major surgery in the 3 months prior to screening
Patients with muscular dystrophies
Patients who have severe comorbid conditions likely to compromise survival or studyparticipation
Pregnant and breast-feeding women
Medical treatment with either a mineralocorticoid receptor antagonist (MRA) or asodium-glucose co-transporter-2 inhibitor (SGLT2i) within 3 months prior toscreening
Medical treatment with potassium binders
Medical treatment with strong or moderate CYP3A4 inducers or inhibitors
Prior serious hypersensitivity reaction to dapagliflozin (Forxiga®), balcinrenone orto any of their excipients
Treatment with cytotoxic therapy, immunosuppressive therapy or other immunotherapywithin 6 months prior to screening
Unwillingness or other inability to cooperate
For patients undergoing MRI scans, presence of implanted devices (surgical clips,heart pacemakers or defibrillators, cochlear implants), iron-based tattoos, anyother pieces of metal or devices that are not MR-safe anywhere in the body
Study Design
Study Description
Connect with a study center
Assistance Publique-Hopitaux de Marseille (AP-HM)
Marseille, 13005
FranceTerminated
Klinikum Nuernberg
Nuremberg, Bavaria 90419
GermanyActive - Recruiting
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