*ARCTIC
Research type
Research Study
Full title
A Phase III, Randomised, Double-Blind, Active-controlled Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure
IRAS ID
1009619
Contact name
Emma Greening
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are trying to find a better way to help people dealing with chronic kidney disease (CKD) and high blood pressure. CKD slowly makes the kidneys work less effectively over time which has a negative impact on overall health. In this study, researchers want to learn if combining two medications together, dapagliflozin and baxdrostat, works better than just using dapagliflozin to slow down the decline in kidney function.
Dapagliflozin helps the heart and kidneys by removing extra sugar and salt through urine. Baxdrostat is a medication that blocks a hormone called aldosterone, which is responsible for raising blood pressure and causing the body to retain fluids. People over 18 years old with CKD and high blood pressure who are already taking blood pressure medications will be part of this study. They will be randomly assigned to two groups: one getting dapagliflozin in combination with baxdrostat, and the other getting dapagliflozin in combination with a placebo (a pill that looks exactly like baxdrostat but has no active ingredient in it).
The main goal of the study is to see if there´s a difference in how fast kidney function declines in both groups. Participants will take the trial medications for about 2 years and 2 months and their health and well-being will be closely watched throughout the trial. The researchers will make sure participants know both the potential risks and benefits associated with the study treatment. This study hopes to find a treatment plan that works better for CKD and high blood pressure, helping those dealing with these conditions to live longer and with a better quality of life.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0041
Date of REC Opinion
13 Mar 2024
REC opinion
Further Information Favourable Opinion