Last updated 12 days ago
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
120 patients around the world
Available in Argentina, United States
Boehringer Ingelheim
4Research sites
120Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.Age 2 to 17 years at screening Visit 1.Chronic kidney disease (CKD) of any underlying aetiology defined by 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.
- 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.
Sites
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Hospital General de Niños Dr. Ricardo Gutierrez
Hospital Público Materno Infantil - Salta
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Chronic kidney disease
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07107945
