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New treatment option for Chronic Kidney Disease
Official title A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
ClinicalTrials.gov ID: NCT07107945
What this study is testing
What is Empagliflozin?
Empagliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney disease.
Also referred to as Jardiance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with...
- 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...
- 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...
- Participants receiving daily immunosuppressive therapy for an underlying immunological cause of CKD must be on a stable dose for the duration...
You likely can't join if
- 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...
- Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment.
See the full eligibility 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...
- 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...
- 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 compared with an inactive...
- 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...
- Further apply.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- Hackensack, New Jersey, United States
- Neptune City, New Jersey, United States
- Albuquerque, New Mexico, United States
+ 75 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; Sacramento, California, United States; San Francisco, California, United States and 89 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.