Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531824
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
EASi-KIDNEY The Studies of Heart Kidney Protection With BI 690517 in Combination With Empagliflozin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter International Randomized Double-blind Placebo-controlled Clinical Trial of the Aldosterone Synthase Inhibitor BI 690517 in Combination With Empagliflozin in Patients With Chronic Kidney Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is open to adults with chronic kidney disease at risk of progression People with and without type 2 diabetes can take part in this study The study is open to people who take other medicines called angiotensin converting enzyme inhibitors ACEi or angiotensin receptor blockers ARB People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor SGLT2i can also join The study is also open to people who currently do not take any of these treatments The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin Worsening of kidney function increases the risk for kidney failure cardiovascular disease and heart disease
This study has 2 parts In the first part participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks Participants continue taking ACEi or ARB throughout the study if such treatments are indicated In the second part participants are divided into 2 groups by chance One group takes BI 690517 tablets and the other group takes placebo tablets Placebo tablets look like BI 690517 tablets but do not contain any medicine Participants take 1 tablet once a day in addition to empagliflozin for the duration of the study
The doctors document when participants experience worsening of their kidney disease go to hospital due to heart failure or die of cardiovascular problems during the study The time to these events is compared between the 2 treatment groups to see whether the treatment works The study continues until the required number of events have occurred which is about 3 to 4 years During this time participants visit the study site about 4 times within the first 6 months Then they visit the study site every 6 months At the visits doctors regularly check participants health take blood and urine samples measure blood pressure and weight check kidney function and take note of any unwanted effects
This study has 2 parts In the first part participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks Participants continue taking ACEi or ARB throughout the study if such treatments are indicated In the second part participants are divided into 2 groups by chance One group takes BI 690517 tablets and the other group takes placebo tablets Placebo tablets look like BI 690517 tablets but do not contain any medicine Participants take 1 tablet once a day in addition to empagliflozin for the duration of the study
The doctors document when participants experience worsening of their kidney disease go to hospital due to heart failure or die of cardiovascular problems during the study The time to these events is compared between the 2 treatment groups to see whether the treatment works The study continues until the required number of events have occurred which is about 3 to 4 years During this time participants visit the study site about 4 times within the first 6 months Then they visit the study site every 6 months At the visits doctors regularly check participants health take blood and urine samples measure blood pressure and weight check kidney function and take note of any unwanted effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None