Last updated: November 16, 2023
Sponsor: Klinikum Nürnberg
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
Dapagliflozin matching Placebo
Balcinrenone 100mg Capsule
Balcinrenone 100mg matching Placebo
Clinical Study ID
NCT05884866
CT114-2022-01
2022-002721-99
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 ranges whenthese 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 childbearing potentialand willingness to use a highly effective birth control (see Appendix 4) if ofchildbearing potential.
- Willingness to participate and ability to provide signed informed consent as describedin Appendix 1 which includes compliance with the requirements and restrictions listedin 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 ventricular ratein 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 bilirubin levels (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 laboratory ranges,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 to screening
- 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, any otherpieces of metal or devices that are not MR-safe anywhere in the body
Study Design
Total Participants: 150
Treatment Group(s): 6
Primary Treatment: Dapagliflozin matching Placebo
Phase: 2
Study Start date:
May 08, 2023
Estimated Completion Date:
January 31, 2025
Study Description
Connect with a study center
Assistance Publique-Hopitaux de Marseille (AP-HM)
Marseille, 13005
FranceActive - Recruiting
Klinikum Nuernberg
Nuremberg, Bavaria 90419
GermanyActive - Recruiting
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