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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
Dong-A University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
January 25, 2022
Last Updated
January 25, 2022
Sponsor
Dong-A University
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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

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