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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age12-25
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2

Disqualifiers

Heart Disease

Diabetes

Pregnancy

Recipient of solid organ transplant

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants who complete all study procedures

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

Time frame
4 years

Secondary outcomes

1

Systolic Blood Pressure

In-clinic systolic blood pressure

Time frame
3 months
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

Measuring using echocardiography

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ann & Robert H Lurie Children's Hospital of Chicago

Lead sponsor

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

Collaborator