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

Dong-A University

Status and phase: Unknown; Phase 4

Conditions: Cardiac Catheterization; Percutaneous Coronary Intervention; Renal Insufficiency, Chronic

Treatments: Drug: Dapagliflozin 10 MG [Farxiga]

Study type: Interventional

Funder types: Other

Identifiers

NCT05225077

PROTECT-CKD

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Dapagliflozin 10mg group

Active Comparator group

Description:

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

Treatment:

Drug: Dapagliflozin 10 MG [Farxiga]

Non-intervention group

No Intervention group

Description:

No intervention.