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NCT05225077 Clinical Trial

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

Percutaneous Coronary Intervention Clinical Trial

Official title:
Effect of Short-term Dapagliflozin on Renal Function After Heart Catheterization or Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05225077
Other study ID # PROTECT-CKD
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2023

Study information
Verified date January 2022
Source Dong-A University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dapagliflozin 10 MG [Farxiga]
Dapagliflozin 10 mg once a day for 1 month after CAG or PCI.

Locations
Country Name City State
Korea, Republic of Dong A University Hospital Busan

Sponsors (1)
Lead Sponsor Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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