APPRECIATE
Research type
Research Study
Full title
Phase 2b Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of AZD2373 in Participants with APOL1-Mediated Kidney Disease (APPRECIATE).
IRAS ID
1011261
Contact name
Stephen Olson
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
The purpose of this study is to learn more about the safety, tolerability, and effectiveness of AZD2373 and to better understand the studied disease, APOL1-Mediated Kidney Disease (AMKD), and associated health problems. People diagnosed with AMKD have a certain change (variant) in the Apolipoprotein L1 (APOL1) gene. The APOL1 gene creates proteins that play a role in immunity. Some people have a variant in the APOL1 gene. APOL1 gene variant is associated with protection against African sleeping sickness. Whilst protecting from one disease, this variant increases the risk of kidney disease in some people. There is currently no approved treatment for AMKD.
AZD2373 is being developed as a potential treatment for AMKD. It works by decreasing the production of the APOL1 protein. Participants will undergo physical examinations, vital signs measurements, blood and urine samples collection, Electrocardiograms and completion of questionnaire and a diary.
About 96 participants will take part in this study which is being conducted in the United Kingdom and the United States. Participants will be in the study for a minimum of 58 weeks.
The study is sponsored by AstraZeneca AB.REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0009
Date of REC Opinion
27 Feb 2025
REC opinion
Further Information Favourable Opinion