A Phase 2b Multicentre, Randomised, Double-Blind, Active-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozinin Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) = 20 mL/min/1.73 m2 - Zenith-CKD

AstraZeneca AB0 sites495 target enrollmentSeptember 7, 2022

Overview

No summary available.

Registry

who.int

Start Date

September 7, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Type of Participant and Disease Characteristics / Laboratory Parameters Diagnosis of CKD, defined as:
•1\. eGFR (CKD\-EPI) \= 20 mL/min/1\.73 m^2
•2\. Urine albumin to creatinine ratio (UACR) \= 150 and \= 5000 mg albumin/g creatinine, based on a single first morning void spot urine sample at screening
•Medical Treatment
•3\. No current or prior (within 1 month of screening) medical treatment with an SGLT2i or any FDC with SGLT2i (such as SGLT2i \+ metformin).
•4\. If ACEi and/or ARB and/or MRA are prescribed, the dose must be stable \= 4 weeks before screening. Participants who have been deemed unable to tolerate ACEi or ARB therapy due to allergy or complications can be enrolled.
•5\. No current or prior treatment within 6 months prior to screening with cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary kidney disease.
•6\. Body mass index (BMI) \= 40 kg/m^2 .
•7\. Male or female of non\-childbearing potential.
•Reproduction

•1\.Minimal change disease, unstable rapidly progressing renal disease, and/or renal disease requiring significant immunosuppression, autosomal dominant or autosomal recessive polycystic kidney disease.
•2\.Participants with NYHA functional HF class III or IV.
•3\.Acute coronary syndrome events within 3 months prior to screening.
•4\.Participants with a BNP\=200pg/mL or NT proBNP\=600pg/mL (BNP\=400pg/mL or
•NT\-proBNP\=1200pg/mL, respectively, if associated with atrial fibrillation) measured by local laboratory at screening (Visit 1\).
•5\.Participants with unstable HF requiring hospitalisation for optimization of HF treatment and/or who have not been stable on HF therapy within 6 months prior to screening.
•6\.Heart failure due to cardiomyopathies that would primarily require other specific treatment: eg, cardiomyopathy due to pericardial disease, amyloidosis or other infiltrative diseases, cardiomyopathy related to congenital heart disease, primary hypertrophic cardiomyopathy,
•cardiomyopathy related to toxic or infective conditions.
•7\.High output HF (eg, due to hyperthyroidism or Paget's disease).
•8\.Heart failure due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement.