Clinical trial • Cardiology|Endocrinology|Nephrology
empagliflozin for Cardiac surgery-associated acute kidney injury|Acute kidney injury
Clinical trial of empagliflozin for Cardiac surgery-associated acute kidney injury|Acute kidney injury.
Overview
- Trial Therapeutic Area
- Cardiology|Endocrinology|Nephrology
- Trial Disease
- Cardiac surgery-associated acute kidney injury|Acute kidney injury
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 09-12-2024
- First CTIS Authorization Date
- 16-01-2025
Trial design
Microcrystalline cellulose (placebo) film-coated tablet (product name: MICROCRYSTALLINE CELLULOSE). Described as 'Placebo'; each film-coated tablet includes 248.75 mg of microcrystalline cellulose; route oral. No explicit dose/schedule for placebo arm stated in the record (placebo matches Jardiance 10 mg tablets).-controlled trial across 1 site in Spain.
- Comparator
- Microcrystalline cellulose (placebo) film-coated tablet (product name: MICROCRYSTALLINE CELLULOSE). Described as 'Placebo'; each film-coated tablet includes 248.75 mg of microcrystalline cellulose; route oral. No explicit dose/schedule for placebo arm stated in the record (placebo matches Jardiance 10 mg tablets).
- Target Sample Size
- 608
- Trial Duration For Participant
- 90
Eligibility
Recruits 608 No vulnerable populations selected. Inclusion requires participants be able to understand the aim of the study and provide written informed consent; no assent or paediatric consent procedures are specified (paediatric subjects excluded by age ≥18)..
- Pregnancy Exclusion
- Pregnant or lactating women
- Vulnerable Population
- No vulnerable populations selected. Inclusion requires participants be able to understand the aim of the study and provide written informed consent; no assent or paediatric consent procedures are specified (paediatric subjects excluded by age ≥18).
Inclusion criteria
- {"criterion_text":"- 1) ≥18 years of age\n- 2) Requiring elective cardiac surgery with ECC\n- 3) Able to understand the aim of the study and to provide written informed consent"}
Exclusion criteria
- {"criterion_text":"- 1) Emergent surgery\n- 2) Endocarditis\n- 3) Patients awaiting heart transplantation\n- 4) Planned use of intra-aortic balloon pump\n- 5) Type 1 diabetes\n- 6) Chronic kidney disease with eGFR <30 mL/min/1.73 m2\n- 7) Severe liver dysfunction (ALT or AST >3 times above the upper limit of normality)\n- 8) Active cancer\n- 9) Active treatment with any SGLT2i\n- 10) Known allergy to empagliflozin, any other SGLT2i or any of its excipients\n- 11) Solid organ transplant recipients\n- 12) Pregnant or lactating women\n- 13) Patients who are participating in another clinical trial"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Composite endpoint of worsening of renal function, defined as a decline in estimated glomerular filtration rate (eGFR) of ≥25%, renal replacement therapy initiation or death during the first 90 days following surgery","definition_or_measurement_approach":"Worsening of renal function defined as a decline in eGFR of ≥25%, initiation of renal replacement therapy, or death during the first 90 days following surgery."}
Recruitment
- Planned Sample Size
- 608
- Recruitment Window Months
- 34
- Consent Approach
- Participants must provide written informed consent; inclusion criterion: 'Able to understand the aim of the study and to provide written informed consent'. A subject information and informed consent form document is listed ('CEIm CONSENTIMIENTO INFORMADO CON MUESTRAS'). No assent procedures or age-specific consent documents are specified. Language specifics not stated.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 608
Spain
- Earliest CTIS Part Ii Submission Date
- 03-01-2025
- Latest Decision Or Authorization Date
- 16-01-2025
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 608
Sites
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- Nephrology
- Principal Investigator Name
- Armando Coca
- Principal Investigator Email
- acoca@saludcastillayleon.es
- Contact Person Name
- Armando Coca
- Contact Person Email
- acoca@saludcastillayleon.es
Sponsor
Primary sponsor
- Full Name
- Hospital Clinico Universitario De Valladolid
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Jardiance 10 mg film-coated tablets
- Active Substance
- empagliflozin
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation EU/1/14/930/014)
- Starting Dose
- 10 mg
- Frequency
- Once daily (perioperative)
- Maximum Dose
- 10 mg per day
- Investigational Product Name
- MICROCRYSTALLINE CELLULOSE
- Active Substance
- microcrystalline cellulose
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Placebo (no marketing authorisation number; marketingAuthNumber='-')
- Starting Dose
- 248.75 mg per tablet
- Maximum Dose
- 248.75 mg per tablet