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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Empagliflozin
Placebo
University of Alabama at Birmingham
Birmingham, Alabama, United States
COMPLETEDStanford University School of Medicine
Palo Alto, California, United States
COMPLETEDUniversity of California Davis
Sacramento, California, United States
COMPLETEDUniversity of California San Francisco
San Francisco, California, United States
COMPLETEDChange 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
Change in estimated glomerular filtration rate (eGFR) (U25Crea) over time during treatment with empagliflozin
U25Crea = estimates the glomerular filtration rate based on creatinine in patients aged up to 25 years
Time frame: Up to week 73
Annual rate of change in eGFR (U25Crea) from the Week 8 to the Week 24 visit, including treatment effect extrapolation from (adult) EMPA-KIDNEY data
Time frame: Up to week 24
Change from Day 1 to the Week 24 visit in urine protein-creatinine ratio (UPCR)
Time frame: Up to week 24
The observed predose plasma concentrations of empagliflozin at the Week 26 visit
Time frame: Up to week 26
Occurrence of at least one SAE or AE of special interest (AESI) per participant between Day 1 and the Week 24 visit, and between the Week 24 visit and end of treatment (EoT) +7 days residual effect period (REP)
SAE= serious adverse event AE= adverse event
Time frame: Up to week 73
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University of Miami
Miami, Florida, United States
COMPLETEDEmory University
Atlanta, Georgia, United States
COMPLETEDAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGNovak Center for Children's Health
Louisville, Kentucky, United States
COMPLETEDJohns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITING...and 83 more locations