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DapaBalci-Leap
EU CTIS ID: 2024-516032-10-00
What this study is testing
To show that treatment with balcinrenone preserves the beneficial dapagliflozin-driven increase in 24h renal glucose excretion
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.