Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430684
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-16
Brief Title:
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SGLT2I-IN-KIDS
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DK138313 | NIH | None | httpsreporternihgovquickSearchK23DK138313 |