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

NCT ID: NCT05225077

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Renal Insufficiency, Chronic Cardiac Catheterization Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dapagliflozin 10mg group

Dapagliflozin 10 mg once a day for 1 month after the procedure.

Group Type ACTIVE_COMPARATOR

Dapagliflozin 10 MG [Farxiga]

Intervention Type DRUG

Dapagliflozin 10 mg once a day for 1 month after CAG or PCI.

Non-intervention group

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dapagliflozin 10 MG [Farxiga]

Dapagliflozin 10 mg once a day for 1 month after CAG or PCI.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A University

OTHER

Sponsor Role lead

Responsible Party

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Moo Hyun Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dong A University Hospital

Busan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Moo Hyun Kim, M.D.

Role: primary

+82-51-240-2976

Other Identifiers

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PROTECT-CKD

Identifier Type: -

Identifier Source: org_study_id

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