NCT07052513 Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery
| NCT ID | NCT07052513 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M2RLAB SL |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2025-12-14 |
| Primary Completion | 2027-06-17 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 98 participants in total. It began in 2025-12-14 with a primary completion date of 2027-06-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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? * What medical problems do participants have when receiving cell therapy? Researchers will compare cell therapy with a placebo (a look-alike substance that contains no drug) to see if cell therapy works to treat AKI. The safety of cell therapy with leukocyte cells will also be studied.
Eligibility Criteria
Inclusion Criteria: 1. Male or female participants older than 18 years of age, being able to understand and sign the Informed Consent. 2. Participants undergoing elective valvular and/or coronary cardiac surgery performed with extracorporeal circulation. 3. Participants must meet one of the following two criteria: 1. 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. 2. Participants that had signed the IC within 12 hours after the AKI diagnosis. 4. 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 (more or equal to 26.4 micromol/L) from baseline, or an increase to more or equal to 150-200 percent (corresponding to a 1.5- to 2-fold increase) from baseline. In addition, the participant must have a positive acute tubular necrosis score within the first 48 hours post cardiac surgery, defined as the presence of at least 3 of the following 4 scenarios: Sodium excretion fraction more than 2 percent, urinary osmolality lower than 400 mOsm/kg, urine sodium more than 40 mmol/L, presence of shock or nephrotoxic agents. AKIN 2: An increase in serum creatinine to more than 200 percent and up to a maximum of 300 percent (corresponding to an increase of more than 2 and up to 3 times) over baseline. AKIN 3: An increase in serum creatinine to more than 300 percent (corresponding to more than 3-fold increase) over baseline, or an increase in serum creatinine levels to more or equal to 4.0 mg/dl (more or equal to 354 micromol/l) with an acute increase of at least 0.5 mg/dl (44 micromol/l). 5. 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 trial. Exclusion Criteria: 1. Chronic Kidney Disease (CKD) in stage IV or V (glomerular filtration rate \[GFR\] less than 30 ml/min). 2. AKI one month prior to heart surgery. 3. Participants who have previously undergone renal replacement therapy. 4. 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. 5. Interstitial glomerulonephritis or vasculitis. 6. Pregnancy. 7. Women in breastfeeding period 8. Renal transplant history. 9. Endocarditis. 10. Participants with mechanical assistance devices: extracorporeal membrane oxygenation (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP). 11. Known severe ventricular dysfunction (left ventricular ejection fraction \[LVEF\] less than 30 percent). 12. Post-surgical septic infectious condition. 13. Clinically significant anemia with hemoglobin values below 100g/l. 14. 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 that the participant has developed AKI. 15. Participants enrolled in another clinical trial testing.
Contact & Investigator
Esteban Poch López de Briñas
PRINCIPAL INVESTIGATOR
Hospital Clinic of Barcelona
Frequently Asked Questions
Who can join the NCT07052513 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07052513 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07052513 currently recruiting?
Yes, NCT07052513 is actively recruiting participants. Contact the research team at pgarciadelariva@m2rlab.com for enrollment information.
Where is the NCT07052513 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT07052513 clinical trial?
NCT07052513 is sponsored by M2RLAB SL. The principal investigator is Esteban Poch López de Briñas at Hospital Clinic of Barcelona. The trial plans to enroll 98 participants.
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