Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants With Proteinuric Chronic Kidney Diseaseclinicaltrials.gov
- Male or Female ≥ 18 years of age
- Body weight within 50-150 kg and body mass index 18 – 45 kg/m^2.
- Proteinuric CKD defined as:
- GFR 20-75 ml/min/1.73m^2
- Albuminuria 200-5000 mg/g
- Females of non-childbearing potential must have been surgically sterilized or be postmenopausal
- Male participants must be surgically sterile or agree to use highly effective contraceptives
- BP ≤ 150/100 mmHg
- Stable dose of angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) for at least 4 weeks OR unable to tolerate ACEi or ARB therapy
- 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).
- Any of the following concomitant conditions or diseases at Screening Visit 1:
- History of QT prolongation associated with other medications that required discontinuation of that medication, and congenital long QT syndrome.
- Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months.
- High degree atrioventricular block II-III, sinus node dysfunction.
- Stroke within 3 months, heart failure, and anticipated dialysis or renal transplantation within 1 year.
- Any other condition or clinically relevant abnormal findings in physical examination, laboratory results or ECG during screening period.
- 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
- Ongoing use of any biologic drug and/or small molecule targeting the immune system
- Treatment with simvastatin, lovastatin, and atorvastatin at doses > 40 mg per day within 1 month
- Concurrent enrollment in another clinical study involving an investigational treatment or drug or participation in a device study within 3 months
- Donation of blood or significant blood loss in excess of 500 mL within 3 months
- Plasma donation within 60 days
- Working night shifts, and cannot avoid strenuous manual labour during the study