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

Boehringer Ingelheim

Status and phase

Begins enrollment in 2 months

Phase 3

Conditions

Chronic Kidney Disease

Treatments

Drug: Placebo

Drug: Empagliflozin

Study type

Interventional

Funder types

Industry

Identifiers

NCT07107945

U1111-1312-1389 (Registry Identifier)

1245-0256

2024-512577-27-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with international council for harmonisation good clinical practice (ICH-GCP) and local legislation prior to admission to the trial (informed assent will be sought according to the patient's age, level of maturity, competence, and capacity).
Age 2 to 17 years at screening Visit 1.
Chronic kidney disease (CKD) of any underlying aetiology defined by (as measured by central laboratory at screening Visit 1): estimated glomerular filtration rate (eGFR) (U25Crea) ≥20 to <90 mL/min/1.73 m2 with a urine-albumine-creatinine (UACR) ≥300 mg/g
Stable standard of care (SoC) CKD treatment for 30 days prior to randomisation with no plans to modify the dose during the trial, at the discretion of the investigator. SoC is anticipated to include a single Renin-angiotensin-aldosterone system (RAAS) inhibitor, such as angiotensin receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEi) as appropriate. Additional use of a mineralocorticoid receptor antagonist (including finerenone if available) is permitted if needed and the dose is stable for 30 days before screening Visit 1 and no planned dose changes
Participants on daily immunosuppressive medication to treat an underlying immunologic cause of CKD must be on a stable dose for 30 days before screening Visit 1 and until randomisation Visit 2. Participants who are taking rituximab or cyclophosphamide should have last taken a dose ≥120 days before screening Visit 1.
Further inclusion criteria apply.

Exclusion criteria

Confirmed type 1 diabetes mellitus.
History of ketoacidosis within 8 weeks prior to Visit 1 and up to randomisation.
Chronic dialysis or functioning kidney transplant or scheduled for transplantation throughout the duration of the trial.
Diagnosis of uncontrolled metabolic bone disease (at the Investigator's discretion).
Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children <4 years of age according to Centers for Disease Control and Prevention (CDC) growth chart at screening Visit 1.
Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment.
Presence of acute or active urinary tract infection (UTI) with signs or symptoms of an active UTI or therapeutic treatment for an active UTI within 14 days before screening Visit 1.
Severe, uncontrolled hypertension (based on investigator's judgement).
Further exclusion criteria apply.