RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-23
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06430684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
  1. * Heart Disease
  2. * Diabetes
  3. * Pregnancy
  4. * Recipient of solid organ transplant
  5. * history of chemotherapy or stem cell transplant
  6. * moderate to severe persistent asthma
  7. * liver disease
  8. * class 2 or greater obesity
  9. * inability to follow study procedures due to cognitive impairment
  10. * obstructive uropathy or requirement for intermittent urinary catheterization
  11. * systolic blood pressure \<100mgHg
  12. * orthostatic hypotension
  13. * current use of an SGLT2i
  14. * anticipated need for titration of anti-hypertensives within 3 months
  15. * active use of any immunosuppressive medications
  16. * lack of clearance by primary nephrologist for participation

Contacts and Locations

Study Contact

Alexander J Kula, MD, MHS
CONTACT
312-227-6160
alexkula@luriechildrens.org

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-23
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-08-23
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Sodium Glucose Co-Transporter 2 Inhibitor
  • SGLT2i
  • Pediatric CKD
  • Feasibility Study
  • Clinical Trial

Additional Relevant MeSH Terms

  • Chronic Kidney Diseases
  • Pediatric Kidney Disease