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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
First received
Last updated
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
Health authority
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

Study Design


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
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