No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 25
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago · Other
Who this trial is looking for
This trial is looking for youth with chronic kidney disease (CKD) to see if a treatment called empagliflozin can help improve kidney and heart health. Participants will either receive this medication or continue their usual care for three months.
Are You a Good Fit for This Trial?
Must not be takingSGLT2i
Rules you outObstructive uropathyCognitive impairmentSystolic blood pressure <100 mmHgOrthostatic hypotensionNeed for anti-hypertensives titrationImmunosuppressive medications
You may be able to join if
I have chronic kidney disease (Stage 3-4).
My estimated kidney function is 20-60 mL/min/1.73m2.
You may not be able to join if
I have heart disease.
I have diabetes.
I am pregnant.
I have received a solid organ transplant.
I have a history of chemotherapy or stem cell transplant.
I have moderate to severe persistent asthma.
I have liver disease.
I have class 2 or greater obesity.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:
1. Is enrolling 40 youth with CKD into a clinical trial o…
The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:
1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?
Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.
Study Procedures Include
* For participants randomly selected for treatment, take empagliflozin once daily for 3 months
* Phone calls with researchers every 2 weeks for check-ins
* For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests
* All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
Exclusion Criteria:
* Heart Disease
* Diabetes
* Pregnancy
* Recipient of solid organ transplant
* history of chemotherapy or stem cell transplant
* moderate to severe persistent asthma
* live…
Inclusion Criteria:
* Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
Exclusion Criteria:
* 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
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