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

Chronic Kidney Diseases Clinical Trial

— SGLT2I-IN-KIDS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430684
• Other study ID #: SGLT2I-IN-KIDS
• Secondary ID: K23DK138313
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 2024
• Est. completion date: December 2028

Study information

• Verified date: May 2024
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Alexander J Kula, MD, MHS
• Phone: 312-227-6160
• Email: alexkula[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Pediatric Kidney Disease
• Renal Insufficiency, Chronic

Intervention

Drug:
• Empagliflozin 10 MG
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

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who complete all study procedures	Compared to the number recruited, how many participants complete the study	4 years
Secondary	Systolic Blood Pressure	In-clinic systolic blood pressure	3 months
Secondary	Serum N-terminal pro-brain natruetic peptide (NT-proBNP)		3 months
Secondary	Urine Albumin to Creatinine Ratio (UACr)		3 months
Secondary	Left Atrial Reservoir Strain	Measuring using echocardiography	3 months