Chronic Kidney DiseasesEarly Phase 1SGLT2I-IN-KIDSNCT06430684
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
A Early Phase 1 study testing Empagliflozin 10 MG in people with Chronic Kidney Diseases and Pediatric Kidney Disease, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Chronic Kidney Diseases, Pediatric Kidney Disease
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2024to 1 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
Who cannot join
- Heart Disease
- Diabetes
- Pregnancy
- Recipient of solid organ transplant
- history of chemotherapy or stem cell transplant
- moderate to severe persistent asthma
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Alexander J Kula, MD, MHS, 312-227-6160, alexkula@luriechildrens.org
About this study
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:
- Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
- Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?
Read more
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
- Conditions
- Chronic Kidney Diseases, Pediatric Kidney Disease
- Being tested
- Empagliflozin 10 MG
- Keywords
- Sodium Glucose Co-Transporter 2 Inhibitor, SGLT2i, Pediatric CKD, Feasibility Study, Clinical Trial
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Empagliflozin is a sodium glucose co-transporter 2 inhibitor (SGLT2i) that is approved for the treatment of chronic kidney disease (CKD) in persons aged 18 years or older
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Empagliflozin 10mg daily for 3 months (n=20) Receives: Drug: Empagliflozin 10 MG |
| Standard of Care | No intervention | Participants will not take empagliflozin (n=20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who complete all study procedures
Compared to the number recruited, how many participants complete the study
Measured: 4 years
Secondary outcomes (4)
Systolic Blood Pressure
In-clinic systolic blood pressure
Measured: 3 months
Serum N-terminal pro-brain natruetic peptide (NT-proBNP)
Measured: 3 months
Urine Albumin to Creatinine Ratio (UACr)
Measured: 3 months
Left Atrial Reservoir Strain
Measuring using echocardiography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start23 Aug 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430684
- Sponsor's protocol ID
- SGLT2I-IN-KIDS
- Other IDs
- K23DK138313
- Acronym
- SGLT2I-IN-KIDS
- Status last verified
- Aug 2026
- First submitted
- 16 May 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
- ClinicalTrials.gov ID
- NCT06430684
- Acronym / sponsor ID
- SGLT2I-IN-KIDS / SGLT2I-IN-KIDS
- Conditions
- Chronic Kidney Diseases, Pediatric Kidney Disease
- Keywords
- Sodium Glucose Co-Transporter 2 Inhibitor, SGLT2i, Pediatric CKD, Feasibility Study, Clinical Trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Empagliflozin 10 MGEmpagliflozin 10mg daily for 3 months (n=20) |
| Standard of Care | No intervention | –Participants will not take empagliflozin (n=20) |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
Key exclusion criteria (16 listed)
- Heart Disease
- Diabetes
- Pregnancy
- Recipient of solid organ transplant
- history of chemotherapy or stem cell transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGEmpagliflozin is a sodium glucose co-transporter 2 inhibitor (SGLT2i) that is approved for the treatment of chronic kidney disease (CKD) in persons aged 18 years or older | Drug | Treatment |
Primary outcome
Percentage of participants who complete all study procedures
Time frame: 4 years
Compared to the number recruited, how many participants complete the study
4 secondary outcomes
Systolic Blood Pressure
Time frame: 3 months
Serum N-terminal pro-brain natruetic peptide (NT-proBNP)
Time frame: 3 months
Urine Albumin to Creatinine Ratio (UACr)
Time frame: 3 months
Left Atrial Reservoir Strain
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Empagliflozin 10 MG in people with Chronic Kidney Diseases and Pediatric Kidney Disease, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander J Kula, MD, MHS (312-227-6160, alexkula@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who complete all study procedures (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.