DapaBalci-Leap

Phase 1

Recruiting

• Conditions: Stage 3 chronic kidney disease; MedDRA version: 20.0Level: SOCClassification code: 10038359Term: Renal and urinary disorders Class: 18; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

• Registration Number: CTIS2024-516032-10-00
• Lead Sponsor: Winicker-Norimed Medizinische Forschung GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-04
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Age: Male and female patients over 50 years old Type of Participant and Disease Characteristics, Diagnosis of chronic kidney disease, with eGFR =30 and =60 mL/min/1.73m2, A) Germany: Serum/ plasma K+ levels = 3.5 and < 5.0 mmol/L OR within normal laboratory ranges when these are provided, within 2 weeks prior to randomization B) France: Serum/ plasma K+ levels = 3.5 and < 5.0 mmol/L within 2 weeks prior to randomization, Serum/plasma Na+ levels within normal reference values within 2 weeks prior to randomization, If participants have type 2 diabetes mellitus, treatment with metformin, sulphonylureas, DPP4 inhibitors or any combinations of these agents with or without insulin would be accepted but is not mandatory. If used, stable dose of metformin, sulphonylureas, or DPP4 inhibitors or their combination as anti-diabetic therapy for the 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 potential 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 as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

Diagnosis of type 1 diabetes mellitus, Significant hepatic disease, including hepatitis and/or liver cirrhosis (Child-Pugh class 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 3 months prior to screening, A) Germany: Hemoglobin levels below 8.5 g/dL or over 15 g/dL OR over the normal laboratory ranges, when these are provided B) France: Hemoglobin levels below 8.5 g/dL or over 15 g/dL, A) Germany: Patients who have received an organ transplant at any time or bone marrow transplant in the previous 10 years B) France: Patients who have received an organ or bone marrow transplant, 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 study participation, Uncontrolled type 2 diabetes mellitus with HbA1C > 10.5% in the most recent medical records, Pregnant and breast-feeding women, Medical treatment with either a mineralocorticoid receptor antagonist (MRA) or a sodium-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 or to any of their excipients, Treatment with cytotoxic therapy, immunosuppressive therapy or other immunotherapy within 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 other pieces of metal or devices that are not MR-safe anywhere in the body, Participants with type 2 diabetes mellitus treated with insulin if insulin dosing (intermediate, long-acting, premixed insulin, basal bolus insulin) was not stable in the 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 for decompensation of heart failure in the 3 months prior to screening, History of any life-threatening cardiac arrhythmias, or uncontrolled ventricular rate in participants with atrial fibrillation or atrial flutter, Acute coronary syndrome and/or percutaneous cardiac interventions within 3 months prior to screening, Unstable or rapidly progressing renal disease, Chronic cystitis and recurrent genital or urinary tract infections

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified