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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Apogee Clinical Research
Huntsville, Alabama, United States
Orange County Clinical Trials
Anaheim, California, United States
North America Research Institute
San Dimas, California, United States
Valiance Clinical Research-Tarzana-68237
Tarzana, California, United States
Amicis Research Center - Valencia
Valencia, California, United States
Focus Clinical Research
West Hills, California, United States
Clinical Research of Brandon LLC
Brandon, Florida, United States
Hillcrest Medical Research
DeLand, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Finlay Medical Research Corp
Miami, Florida, United States
Start Date
July 18, 2025
Primary Completion Date
August 20, 2026
Completion Date
August 20, 2026
Last Updated
March 18, 2026
416
ESTIMATED participants
Vicadrostat
DRUG
Empagliflozin
DRUG
Placebo matching vicadrostat
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT07241390
NCT06717698
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07450820