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NCT Number: NCT06430684

Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease

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

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Kidney Disease Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Alexander J Kula, MD, MHS

CONTACT

[email protected]

312-227-6160

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin 10 MG

Drug

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

Primary outcomes

  1. Percentage of participants who complete all study procedures

    Time frame: 4 years

    Compared to the number recruited, how many participants complete the study

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: 3 months

    In-clinic systolic blood pressure

  2. Serum N-terminal pro-brain natruetic peptide (NT-proBNP)

    Time frame: 3 months

  3. Urine Albumin to Creatinine Ratio (UACr)

    Time frame: 3 months

  4. Left Atrial Reservoir Strain

    Time frame: 3 months

    Measuring using echocardiography

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander J Kula, MD, MHS

CONTACT

[email protected]

312-227-6160

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: SGLT2I-IN-KIDS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 28, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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