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Modified autologous leukocyte cells for the treatment of acute kidney injury after cardiac surgery
EU CTIS ID: 2023-504610-30-01
What this study is testing
1. Assessment of the efficacy of cell therapy versus placebo by measuring the time to recovery of renal function in patients who develop AKI within 48 h after cardiac surgery. 2. To assess the safety and tolerability of cell therapy versus placebo in patients who develop AKI within 48 h after cardiac surgery.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of both sexes over 18 years of age being able to understand and sign the informed consent.
- Patients undergoing elective or emergent valvular and/or coronary heart surgery performed with extracorporeal circulation.
- Meet one of the following two criteria: a) Present a preoperative AKI risk ≥ 30% according to the Leicester Cardiosurgery score, if the informed consent form (ICF) is signed before cardiac surgery. b) Have signed the ICF within the first 12 hours after the diagnosis of AKI
- Present AKI in the first 48 hours after cardiac surgery, according to one of the classifications defined by the AKIN (Acute Kidney Injury Network) scale.
- In the case of women or men of childbearing age, for safety, those who agree to follow the required contraceptive measures from hospital discharge until the end of their participation in the clinical trial.
You likely can't join if
- Stage IV or V CKD (glomerular filtration rate [GFR] < 30 ml/min)
- Patients with mechanical assist devices: extracorporeal membrane oxygenator (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP).
- Known severe ventricular dysfunction (left ventricular ejection fraction [LVEF] <30%)
- Post-surgical septic infection.
- Clinically significant anemia with hemoglobin values below 100 g/L.
- Positive serologies for hepatitis C virus (HCV), hepatitis B virus antigen (HBSAg), human immunodeficiency virus (HIV) or syphilis (by RPR: rapid plasma reagin). This criterion will be evaluated once it has been confirmed that the patient has developed AKI.
See the full eligibility criteria
- Patients of both sexes over 18 years of age being able to understand and sign the informed consent.
- Patients undergoing elective or emergent valvular and/or coronary heart surgery performed with extracorporeal circulation.
- Meet one of the following two criteria: a) Present a preoperative AKI risk ≥ 30% according to the Leicester Cardiosurgery score, if the informed consent form (ICF) is signed before cardiac surgery. b) Have signed the ICF within the first 12 hours after the diagnosis of AKI
- Present AKI in the first 48 hours after cardiac surgery, according to one of the classifications defined by the AKIN (Acute Kidney Injury Network) scale.
- In the case of women or men of childbearing age, for safety, those who agree to follow the required contraceptive measures from hospital discharge until the end of their participation in the clinical trial.
- Stage IV or V CKD (glomerular filtration rate [GFR] < 30 ml/min)
- Patients with mechanical assist devices: extracorporeal membrane oxygenator (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP).
- Known severe ventricular dysfunction (left ventricular ejection fraction [LVEF] <30%)
- Post-surgical septic infection.
- Clinically significant anemia with hemoglobin values below 100 g/L.
- Positive serologies for hepatitis C virus (HCV), hepatitis B virus antigen (HBSAg), human immunodeficiency virus (HIV) or syphilis (by RPR: rapid plasma reagin). This criterion will be evaluated once it has been confirmed that the patient has developed AKI.
- Participation in another clinical intervention test
- AKI in the month prior to cardiac surgery.
- Patients who have previously undergone renal replacement therapy.
- Patients who, due to their clinical condition (hemodynamic instability, oliguria, present or foreseeable volume overload), are expected to start renal replacement therapy within 48 hours after diagnosis of AKI.
- Interstitial glomerulonephritis or vasculitis.
- Pregnancy.
- Breastfeeding women.
- History of renal transplant.
- Endocarditis.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.