Short-term Use of Dapagliflozin to Protect Kidney Functio... | NCT05225077

Studies
Short-term Use of Dapagliflozin to Protect Kidney Function in CKD Patients

NCT05225077

Sponsor

Dong-A University

Status

Unknown status

Last Update Posted

Feb 4, 2022Actual

Enrollment

600Estimated

Phase

Phase 4

Conditions

Renal Insufficiency, Chronic
Cardiac Catheterization
Percutaneous Coronary Intervention

Interventions

Dapagliflozin 10 MG [Farxiga]

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jan 25, 2022

First Submission Date that Met QC Criteria

Jan 25, 2022

First Posted Date

Feb 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2022

Last Update Posted Date

Feb 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dapagliflozin 10mg group	Active Comparator	Dapagliflozin 10 mg once a day for 1 month after the procedure.	Drug: Dapagliflozin 10 MG [Farxiga]
Non-intervention group	No Intervention	No intervention.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin 10 MG [Farxiga]	Drug	Dapagliflozin 10 mg once a day for 1 month after CAG or PCI.	Dapagliflozin 10mg group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of contrast induced nephropathy	Serum creatinine (Scr) elevation of >25% or >0.5 mg/dl (44 μmol/l) from baseline within 48 hours	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dong A University Hospital	Recruiting	Busan		602-715	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C529054	dapagliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided