Active Cancer NIHR-supported project Diabetes, Hormones & Metabolism

APPRECIATE: Phase 2 Multicentre, Randomised, 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)

In plain English

AI plain-English summary

A drug called AZD2373 is being tested in 96 people with a genetic form of kidney disease to see if it can safely slow or stop the damage. This matters because people with APOL1-Mediated Kidney Disease (AMKD) carry a gene variant that once protected against African sleeping sickness but now puts them at high risk of kidney failure. There is currently no approved treatment for this condition. The drug works by reducing production of the APOL1 protein, which is thought to drive the disease. If the trial shows AZD2373 is safe and effective, it could become the first targeted therapy for AMKD. That would change the outlook for a group of patients—disproportionately of African ancestry—who currently face a high likelihood of progressing to dialysis or needing a kidney transplant. The study runs for at least 58 weeks across sites in the UK and US, and is sponsored by AstraZeneca.

View original technical description
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.

Researchers

Melanie Chan (Principal Investigator)

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