A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)

Conditions

• Chronic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin — DRUG
  Empagliflozin
• Placebo — DRUG
  Placebo

Study Details

This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD. Participants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year. Participants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.

Key Dates

First listed

Aug 6, 2025

Start date

Dec 9, 2025

Status verified

Sep 2026

Primary completion

Apr 16, 2027

Completion

Apr 14, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Empagliflozin treatment arm
• Placebo Comparator: Placebo arm

Primary Outcome Measure

Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g] [ Time Frame: Up to week 24 ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (25)

Find similar trials in Birmingham, AL

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