A Randomised, Double-Blind, Placebo-Controlled Trial with an Open-Label Extension to Assess the Pharmacokinetics, Safety, and Efficacy of Empagliflozin Tablets in Paediatric Patients with Chronic Kidney Disease (Empa-Kidney Kids)

Study on Investigational Medication for Children with Kidney Damage

M
Myda Khalid

Primary Investigator

Enrolling By Invitation
2 years - 17 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Kidney Disease, CKD, Riley
  • Age: 2 years - 17 years
  • Gender: All

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.

This study investigates how an investigational medication affects children and teenagers with chronic kidney disease (CKD). Chronic kidney disease is a condition where the kidneys are damaged and cannot filter blood as well as they should. The purpose of this study is to see if the investigational medication is safe and how it is processed by the body in young patients.

Participants in the study are divided into two study arms. One arm receives the investigational medication, while the other receives a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. Participants take their assigned tablets once a day for 6 months. After this period, all participants take the investigational medication for another year. During the study, doctors will collect blood and urine samples and monitor participants' health.

  • Who can participate: Children aged 2 to 17 with chronic kidney disease can participate if they have stable treatment and are not scheduled for a kidney transplant. They should not have type 1 diabetes or recent ketoacidosis.
  • Study details: Participants will take tablets once a day and attend regular health check-ups. They will be randomly assigned to receive either the investigational medication or a placebo for the first 6 months.
  • Study timelines and visits: The study will last 1.5 years. The study requires 15 visits.
Updated on 07 Apr 2026. Study ID: PNEPH-BOEINGLE-1245-0256, 28308
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only