Chronic Kidney Diseases study: Empagliflozin
Official title Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
ClinicalTrials.gov ID: NCT06430684
What this study is testing
What is Empagliflozin 10 MG?
An investigational oral tablet being studied as a potential treatment for chronic kidney disease in youth. It is designed to block the sodium‑glucose co‑transporter‑2 (SGLT2) in the kidneys, reducing glucose reabsorption and increasing urinary glucose excretion.
Also referred to as Empagliflozin, 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
- The study wants to see if it is possible to enroll youth with chronic kidney disease and whether a 3‑month course of empagliflozin changes blood, urine or heart test results.
- Who it's for
- Kids and teenagers who have chronic kidney disease.
- What's involved
- Participants are randomly assigned to take empagliflozin once daily or continue usual care. Those on the drug have clinic visits at 4 and 8 weeks and phone check‑ins every 2 weeks; all participants have visits at the start and after 3 months for health checks and tests.
- Time commitment
- The trial lasts about 3 months with visits at the beginning, at 4 weeks, 8 weeks, and at the end, plus bi‑weekly phone calls for those on the drug.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 25
You may be able to join if
- Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
You likely can't join if
- Heart Disease
- Diabetes
- Pregnancy
- Recipient of solid organ transplant
- history of chemotherapy or stem cell transplant
- moderate to severe persistent asthma
See the full eligibility criteria
- Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
- Heart Disease
- Diabetes
- Pregnancy
- Recipient of solid organ transplant
- history of chemotherapy or stem cell transplant
- moderate to severe persistent asthma
- liver disease
- class 2 or greater obesity
- inability to follow study procedures due to cognitive impairment
- obstructive uropathy or requirement for intermittent urinary catheterization
- systolic blood pressure \<100mgHg
- orthostatic hypotension
- current use of an SGLT2i
- anticipated need for titration of anti-hypertensives within 3 months
- active use of any immunosuppressive medications
- lack of clearance by primary nephrologist for participation
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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, 12 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.