Short-term Use of Dapagliflozin to Protect Kidney Function in CKD Patients
Primary Purpose
Renal Insufficiency, Chronic, Cardiac Catheterization, Percutaneous Coronary Intervention
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dapagliflozin 10 MG [Farxiga]
Sponsored by
About this trial
This is an interventional prevention trial for Renal Insufficiency, Chronic focused on measuring Sodium-Glucose Transporter 2 Inhibitors, Dapaglifozin, Chronic kidney disease
Eligibility Criteria
Inclusion Criteria:
- Age>18 years
- Written informed consent
- Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 [CKD stage G1-G3]
- Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients
Exclusion Criteria:
- Active malignancy
- Class I or equivalent indication for treatment with a SGLT2 inhibitor
- Pregnancy or willing of pregnancy during the follow up period
- Active urogenital infection
- Diabetes mellitus type 1
- History of diabetic ketoacidosis
- Cardiogenic shock
- eGFR < 29 ml/min/1.73m2
Sites / Locations
- Dong A University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Dapagliflozin 10mg group
Non-intervention group
Arm Description
Dapagliflozin 10 mg once a day for 1 month after the procedure.
No intervention.
Outcomes
Primary Outcome Measures
Incidence of contrast induced nephropathy
Serum creatinine (Scr) elevation of >25% or >0.5 mg/dl (44 μmol/l) from baseline within 48 hours
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05225077
Brief Title
Short-term Use of Dapagliflozin to Protect Kidney Function in CKD Patients
Official Title
Effect of Short-term Dapagliflozin on Renal Function After Heart Catheterization or Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aim to investigate the protected effects of short-term use of dapagliflozin (administered within 3 days after procedure) in CKD patients after coronary angiography or percutaneous coronary intervention, as well as observed the incidence of CIN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Cardiac Catheterization, Percutaneous Coronary Intervention
Keywords
Sodium-Glucose Transporter 2 Inhibitors, Dapaglifozin, Chronic kidney disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin 10mg group
Arm Type
Active Comparator
Arm Description
Dapagliflozin 10 mg once a day for 1 month after the procedure.
Arm Title
Non-intervention group
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10 MG [Farxiga]
Intervention Description
Dapagliflozin 10 mg once a day for 1 month after CAG or PCI.
Primary Outcome Measure Information:
Title
Incidence of contrast induced nephropathy
Description
Serum creatinine (Scr) elevation of >25% or >0.5 mg/dl (44 μmol/l) from baseline within 48 hours
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age>18 years
Written informed consent
Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 [CKD stage G1-G3]
Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients
Exclusion Criteria:
Active malignancy
Class I or equivalent indication for treatment with a SGLT2 inhibitor
Pregnancy or willing of pregnancy during the follow up period
Active urogenital infection
Diabetes mellitus type 1
History of diabetic ketoacidosis
Cardiogenic shock
eGFR < 29 ml/min/1.73m2
Facility Information:
Facility Name
Dong A University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moo Hyun Kim, M.D.
Phone
+82-51-240-2976
Email
kimmh@dau.ac.kr
12. IPD Sharing Statement
Learn more about this trial
Short-term Use of Dapagliflozin to Protect Kidney Function in CKD Patients
We'll reach out to this number within 24 hrs