A trial to learn how well balcinrenone in combination with dapagliflozin works and how safe it is compared to dapagliflozin alone in adults with chronic kidney disease

Phase 1

Recruiting

• Conditions: Chronic Kidney Disease and Albuminuria; MedDRA version: 23.1Level: PTClassification code: 10064848Term: Chronic kidney disease Class: 100000004857; Therapeutic area: Phenomena and Processes [G] - Metabolism [G03]

• Registration Number: CTIS2023-509709-63-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-18
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Age = 18 years old, 2.Diagnosis of CKD and eGFR = 25 to < 60 mL/min/1.73 m2., 3. UACR > 100 mg/g (10 mg/mmol) to = 5000 mg/g (500 mg/mmol)., 4. Serum potassium = 3.5 mmol/L to = 5.0 mmol/L., 5. Stable RAAS inhibitors treatment for 4 weeks before screening. Participants who cannot tolerate or are not treated with RAAS inhibitors can also participate in the study.

Exclusion Criteria

1. Uncontrolled arterial hypertension (SBP > 160 mmHg or DBP > 100 mmHg)., 10. Serum HCO3 < 18 mmol/L at screening., 11. Adrenal insufficiency (eg, Addison's disease, prolonged use of glucocorticoids)., 12. Any use of the following within 4 weeks prior to screening: - MRA (or planned initiation of MRA treatment), potassium sparing diuretic, potassium binders, fludrocortisone. - Strong or moderate CYP3A4 inducers or inhibitors prohibited at least 1 week prior to randomisation and during treatment., 2. Hypotension defined as SBP < 100 mmHg., 3. Autosomal dominant polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis or other nephropathies that are unstable or progress rapidly., 4. Cytotoxic or immunomodulatory therapy within 6 months prior to screening, or current, or planned within 6 months following randomization., 5. History of solid organ or bone marrow transplantation, 6. Recent (90 d prior to screening) or ongoing dialysis, or likely need for dialysis within 3 months following randomization., 7. Myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous 12 weeks., 8. Type 1 diabetes mellitus (DM) or uncontrolled type 2 DM., 9. Hepatic disease, including active hepatitis, and/or hepatic impairment (Child-Pugh class B-C; or any of AST or ALT > 3 × ULN; or TBL > 2 × ULN.

Study & Design

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