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

Phase 1

Recruiting

• Conditions: Chronic Kidney Diseases; Pediatric Kidney Disease

• Registration Number: NCT06430684
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2<br><br>Exclusion Criteria:<br><br> - Heart Disease<br><br> - Diabetes<br><br> - Pregnancy<br><br> - Recipient of solid organ transplant<br><br> - history of chemotherapy or stem cell transplant<br><br> - moderate to severe persistent asthma<br><br> - liver disease<br><br> - class 2 or greater obesity<br><br> - inability to follow study procedures due to cognitive impairment<br><br> - obstructive uropathy or requirement for intermittent urinary catheterization<br><br> - systolic blood pressure <100mgHg<br><br> - orthostatic hypotension<br><br> - current use of an SGLT2i<br><br> - anticipated need for titration of anti-hypertensives within 3 months<br><br> - active use of any immunosuppressive medications<br><br> - lack of clearance by primary nephrologist for participation

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants who complete all study procedures

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure;Serum N-terminal pro-brain natruetic peptide (NT-proBNP);Urine Albumin to Creatinine Ratio (UACr);Left Atrial Reservoir Strain