EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)

Conditions

• Kidney Disease, Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BI 690517 — DRUG
  BI 690517 (called Type M randomized treatment)
• Placebo matching BI 690517 — DRUG
  Placebo matching BI 690517
• Empagliflozin — DRUG
  Empagliflozin (called Type E)

Study Details

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 failure hospitalisation. After a run-in period, during which participants are confirmed to be receiving clinically appropriate renin-angiotensin system blockade and are established on empagliflozin, they are randomly assigned (by chance) to 1 of 2 groups. One group receives BI 690517 tablets, and the other group receives placebo tablets. Placebo tablets look like BI 690517 but do not contain any medicine. Participants take 1 study 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 5 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.

Key Dates

First listed

Aug 1, 2024

Start date

Aug 30, 2024

Status verified

Sep 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

11,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Part 1: Run-in period (all participants)
  * Participant will receive empagliflozin (called Type E) together with study tablets (called Type F) prior to later randomisation to the main study treatment (Type M). * This run-in period allows empagliflozin to be established and have its effects on kidney function before randomisation, and to make sure participant can tolerate empagliflozin long-term. Participants will not routinely know whether type F treatment is active or inactive so that participants can become familiar with taking main study tablet (Type M) after randomization.
• Experimental: Part 2: Randomized treatment, follow-up period, treatment group
• Placebo Comparator: Part 2: Follow-up period, placebo group

Primary Outcome Measure

Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death. [ Time Frame: up to 4 years ]

Locations (52)

Find similar trials in Huntsville, AL

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