Recruiting
Phase 3

Empagliflozin

Sponsor:

Boehringer Ingelheim

Code:

NCT07107945

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Empagliflozin

Placebo

Study Details

Brief summary:

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.

Conditions

Chronic Kidney Disease

Study ID

NCT07107945

Start date

Dec 9, 2025

Status verified date

Aug, 2026

Completion date

Apr 14, 2028

Anticipated

Primary completion date

Apr 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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
  • Participants must be on a stable dose of maximally tolerated standard of care (SoC) therapy for 30 days before screening visit 1 with no plans to change the dose throughout the duration of the placebo-controlled duration of the trial. 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 and tolerated. Additional use of a mineralocorticoid receptor antagonist (MRA, 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 for the placebo-controlled portion of the trial.
  • Participants receiving daily immunosuppressive therapy for an underlying immunological cause of CKD must be on a stable dose for the duration specified for each drug prior to screening and must remain on a stable regimen throughout the placebo-controlled portion of the trial.
  • Further inclusion criteria apply.

Exclusion Criteria:

  • Confirmed type 1 or type 2 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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empagliflozin treatment arm

placebo comparator: Placebo arm

Interventions

Empagliflozin

Empagliflozin

Placebo

Placebo

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 ]
  • Change from Day 1 to the Week 24 visit in urine glucose [mmol/L] [ Time Frame: Up to week 24 ]

Central Contacts and Locations

Central contacts

Boehringer Ingelheim

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Locations

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Novak Center for Children's Health

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

M Health Fairview Masonic Children's Hospital

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Virginia Commonwealth University Health Systems

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

University of Alberta Hospital (University of Alberta)

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

McGill University Health Centre (MUHC)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

Jim Pattison Children's Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-08-20.