A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants with Proteinuric Chronic Kidney Disease

Exclusion Criteria

• • Participants with recent positive hepatitis B or hepatitis C.
• • Diagnosis of polycystic kidney disease or anatomical causes of CKD.
• • Diagnosis of Type 1 DM.
• • Participants with severe hepatic impairment (Child-Pugh class C).
• • Abnormal laboratory findings at Screening Visit 1.
• • Any of the following concomitant conditions or diseases at Screening Visit 1:
• a) History of QT prolongation associated with other medications that required discontinuation of that medication, and congenital long QT syndrome.
• b) Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months.
• c) High degree atrioventricular block II-III, sinus node dysfunction.
• d) Stroke within 3 months, heart failure, and anticipated dialysis or renal transplantation within 1 year.
• e) Any other condition or clinically relevant abnormal findings in physical examination, laboratory results or ECG during screening period.
• f) History of substance dependence or a positive screen for drugs or alcohol abuse. Alcohol and drug screening to be completed for all participants locally with laboratory kits provided by the central laboratory.
• • Participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks of Screening Visit 1.
• • Ongoing use of any biologic drug and/or small molecule targeting the immune system.
• • Any serum creatinine-altering drugs within 1 month prior to Screening Visit 1.
• • Treatment with any concomitant medications known to be associated with Torsades de Pointes or potent inducers/inhibitors of cytochrome P450 3A4 within 4 weeks of Visit 3 (Randomization).
• • Treatment with zileuton, cilastatin (dipeptidase-1 [DPEP1] inhibitor), or leukotriene receptor antagonists (eg, montelukast) within 4 weeks of Screening Visit 1.
• • Treatment with simvastatin, lovastatin, and atorvastatin at doses > 40 mg per day within 1 month prior to Screening Visit 1.
• • Concurrent enrollment in another clinical study involving an investigational treatment or drug or participation in a device study within 3 months prior to Screening Visit 1.
• • Participants with a known hypersensitivity to AZD5718 or any of the excipients of the product. Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product.
• • Donation of blood or significant blood loss in excess of 500 mL within 3 months prior to Day 1 (or > 1200 mL in the year prior to Day 1).
• • Plasma donation within 60 days prior to Day 1.
• • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study center).
• • Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
• • For women only - currently pregnant (a negative serum pregnancy test is required at Screening Visit 1 and urine pregnancy test at Day 1 [Visit 3]) or breast-feeding.
• • An employee, or close relative of an employee, of AstraZeneca, the Contract Research Organisation, or the study site, regardless of the employee’s role.
• • Participants who are legally institutionalized.
• • Participants working night shifts, and who cannot avoid strenuous manual labour during the study.