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

In by ECIR

Locations
Macon
Condition
Kidney Disease

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

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A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants With Proteinuric Chronic Kidney Disease

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Male or Female ≥ 18 years of age
  2. Body weight within 50-150 kg and body mass index 18 – 45 kg/m^2.
  3. Proteinuric CKD defined as:
    • GFR 20-75 ml/min/1.73m^2
    • Albuminuria 200-5000 mg/g
  4. Females of non-childbearing potential must have been surgically sterilized or be postmenopausal
  5. Male participants must be surgically sterile or agree to use highly effective contraceptives
  6. BP ≤ 150/100 mmHg
  7. 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

 

Exclusion Criteria
  1. Participants with recent positive hepatitis B or hepatitis C.
  2. Diagnosis of polycystic kidney disease or anatomical causes of CKD
  3. Diagnosis of Type 1 DM
  4. Participants with severe hepatic impairment (Child-Pugh class C).
  5. 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.
  6. 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
  7. Ongoing use of any biologic drug and/or small molecule targeting the immune system
  8. Treatment with simvastatin, lovastatin, and atorvastatin at doses > 40 mg per day within 1 month
  9. Concurrent enrollment in another clinical study involving an investigational treatment or drug or participation in a device study within 3 months
  10. Donation of blood or significant blood loss in excess of 500 mL within 3 months
  11. Plasma donation within 60 days
  12. Working night shifts, and cannot avoid strenuous manual labour during the study
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