Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery (NCT07052513) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery
Spain98 participantsStarted 2025-07-17
Plain-language 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 patients 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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.
✓. Present pre-operative AKI risk more or equal to 30 percent according to the Leicester Cardiosurgery scale.
✓. 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):
✓. 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
✕. 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 therapy.
What they're measuring
1
Recovery time of kidney function
Timeframe: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment)
2
Proportion of participants with persistently altered creatinine values (more than 31 percent from baseline values) 7 days after AKI episode
Timeframe: Baseline Phase (Day 0), Observation Phase: From Visit 1 (1 day after treatment) to Visit 7 (7 days after treatment
3
Occurrence of adverse events (AEs)
Timeframe: Up to Day 90
4
Occurrence of serious AEs (SAEs)
Timeframe: Up to Day 90
5
Occurrence of AEs resulting in discontinuation of study treatment