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New treatment option for Acute Kidney Injury
Official title Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery
ClinicalTrials.gov ID: NCT07052513
What this study is testing
What is M2RLAB 001?
M2RLAB 001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute kidney injury.
Also referred to as Autologous Leukocyte Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical trial is to assess the efficacy and safety of cell therapy with modified leukocyte cells from the participant himself/herself versus placebo in participants who develop Acute Kidney Injury (AKI) within the first 48 hours after cardiac surgery. The main questions it aims to answer are: Does cell therapy reduce the recovery time of kidney function?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female participants older than 18 years of age, being able to understand and sign the Informed Consent.
- Participants undergoing elective valvular and/or coronary cardiac surgery performed with extracorporeal circulation.
- Participants must meet one of the following two criteria:
- Present pre-operative AKI risk more or equal to 30 percent according to the Leicester Cardiosurgery scale, in case the participants had signed the IC...
- Participants that had signed the IC within 12 hours after the AKI diagnosis.
You likely can't join if
- Chronic Kidney Disease (CKD) in stage IV or V (glomerular filtration rate [GFR] less than 30 ml/min).
- AKI one month prior to heart surgery.
- Participants who have previously undergone renal replacement therapy.
- Participants who, due to their clinical situation (hemodynamic instability, oliguria, current or anticipated volume overload) are scheduled to start...
- Interstitial glomerulonephritis or vasculitis.
- Pregnancy.
See the full eligibility criteria
- Male or female participants older than 18 years of age, being able to understand and sign the Informed Consent.
- Participants undergoing elective valvular and/or coronary cardiac surgery performed with extracorporeal circulation.
- Participants must meet one of the following two criteria:
- Present pre-operative AKI risk more or equal to 30 percent according to the Leicester Cardiosurgery scale, in case the participants had signed the IC before.
- Participants that had signed the IC within 12 hours after the AKI diagnosis.
- Present AKI within the first 48 hours post cardiac surgery in one of the following classifications defined by the AKIN scale (Acute Kidney Injury Network): AKIN 1: An increase in serum creatinine by at least 0.3 mg/dL...
- In the case of women or men of childbearing age, for safety, those who undertake to follow the contraceptive measures required from their discharge from hospital until the end of their participation in the clinical...
- Chronic Kidney Disease (CKD) in stage IV or V (glomerular filtration rate [GFR] less than 30 ml/min).
- AKI one month prior to heart surgery.
- Participants who have previously undergone renal replacement therapy.
- Participants who, due to their clinical situation (hemodynamic instability, oliguria, current or anticipated volume overload) are scheduled to start renal replacement therapy within the next 48 hours after AKI diagnosis.
- Interstitial glomerulonephritis or vasculitis.
- Pregnancy.
- Women in breastfeeding period
- Renal transplant history.
- Endocarditis.
- Participants with mechanical assistance devices: extracorporeal membrane oxygenation (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] less than 30 percent).
- Post-surgical septic infectious condition.
- Clinically significant anemia with hemoglobin values below 100g/l.
- Positive serology 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 assessed once it has been confirmed...
- Participants enrolled in another clinical trial testing.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Catalonia, Spain
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Catalonia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.