A Phase II Randomised, Double-blind, Parallel-group, Multicentre, International Trial to Investigate the Safety and Efficacy of Vicadrostat and Empagliflozin Administered With Simultaneous vs Staggered Initiation in Participants With Chronic Kidney Disease at Risk of Kidney Disease Progression
A Phase II Randomised, Double-blind, Parallel-group, Multicentre, International Trial to Investigate the Safety and Efficacy of Vicadrostat and Empagliflozin Administered With Simultaneous vs Staggered Initiation in Participants With Chronic Kidney Disease at Risk of Kidney Disease Progression
This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse. People who have taken a specific type of medication for kidney disease called SGLT2 inhibitor within 1 month before the study or have certain health conditions cannot take part in this study. The purpose of this study is to find out whether a medicine called vicadrostat, used in combination with another medicine called empagliflozin, works in people with chronic kidney disease.
In this study, participants are randomly assigned to one of two groups. Participants have an equal chance of being assigned to either group. In one group, participants take the 2 study medicines, vicadrostat and empagliflozin, every day for 3 months. In the other group, participants take placebo and empagliflozin for the first 1.5 months, and then they take vicadrostat and empagliflozin together for the next 1.5 months. The study medicines are taken orally as tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine.
Participants are in the study for about 4.5 months. During this time, they visit the study site multiple times. Doctors regularly test kidney function by measuring specific proteins in the blood and urine.
The results are compared between the two groups to see whether there are differences between starting the study medicines at the same time or one after the other. The doctors also regularly check participants' health and take note of any unwanted effects.
Inclusion Criteria:
Exclusion Criteria:
Further exclusion criteria apply.
Hinsdale, Illinois 60521, United States
Fort Wayne, Indiana 46804, United States
CABA, C1060ABN, Argentina
CABA, C1128AAF, Argentina
São José do Rio Preto, 15090-000, Brazil
Ningxia, 750004, China
Aichi, Kasugai, 486-8510, Japan
Chiba, Chiba, 260-8712, Japan
Ibaraki, Tsuchiura, 300-0028, Japan
Kanagawa, Yokohama, 234-0054, Japan
Osaka, Osaka, 558-8558, Japan
Osaka, Suita, 565-0853, Japan
Saitama, Ageo, 362-8588, Japan
Shiga, Omihachiman, 523-0082, Japan
Tokyo, Hachioji, 193-0998, Japan
Kapiti, Wellington Region 5036, New Zealand
Centelles, Barcelona, 08540, Spain