This clinical trial is designed to evaluate KELI-101 versus placebo for the prevention of acute kidney disease leading to chronic kidney disease in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive KELI-101, while the other half will receive a placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
KELI-101 consists of ex vivo expanded placental mesenchymal stromal cells (PMSCs) in a 10% cryopreservation solution.
Plasmalyte
Treatment-emergent adverse events (TEAE)
To assess the acute and middle-term toxicity of the intrarenal arterial administration of KELI -101
Time frame: From KELI -101 administration up to Day 90
Ratio of the acute kidney disease (AKD) leading to chronic kidney disease (CKD)
To assess the effect of KELI -101 on AKD leading to CKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Time frame: From baseline to Day 90
Adverse events (AE) and adverse drug reactions (ADRs)
To assess tolerability and all AE (related or not related to study drug) after IRA administration of KELI -101
Time frame: From KELI -101 administration up to Day 90
Serious AE (SAE) and Serious ADRs (SADRs)
To assess all serious AE (related or not related to study drug) after IRA administration of KELI -101
Time frame: From KELI -101 administration up to Day 90
Ratio of the highest SCr value within 6 days post-dose versus baseline
To assess the effect of KELI -101 on SCr level, versus mean matched historical control SCr level
Time frame: From baseline to Day 7
AKI stages 1, 2 and 3 as defined by modified AKI Network criteria
To assess the effect of KELI -101 on the incidence and severity of AKI in high-risk patients undergoing major cardio-vascular surgery, versus mean matched historical control SCr level For historical control: To assess the incidence and severity of AKI in high-risk patients undergoing major cardiovascular surgery in relation to preoperative Scr levels.
Time frame: From baseline to Day 7
Ratio of the duration of AKI/AKD at Day 28
To assess the effect of KELI -101 on duration of AKI/AKD
Time frame: From baseline to Day 28
Ratio of incidence and duration of renal replacement therapy (RRT) Day 28
To assess the effect of KELI -101 on incidence and duration of RRT
Time frame: From baseline to Day 28
Occurrence of major adverse kidney event (MAKE) at Day 7/10/30/90 (MAKE7/10/30/90)
To assess the effect of KELI -101 on Major Adverse Kidney Events composite (MAKE7/10/30/90)
Time frame: From Day 7 to Day 90
Occurrence of major adverse reno cardiovascular event at Day 7/10/30/90 (MARCE7/10/30/90)
To assess the effect of KELI -101 on Major Adverse Reno Cardiovascular Events composite (MARCE7/10/30/90)
Time frame: From Day 7 to Day 90
Ratio of the AKI leading to CKD
To assess the effect of KELI -101 on incidence of AKI to CKD transition;
Time frame: From baseline to Day 90
Ratio of duration of stay in ICU
To assess the effect of KELI -101 on length of ICU-stay
Time frame: From baseline to discharge from ICU
Ratio of incidence and completeness of recovery of AKI/AKD at Day 90
To assess the effect of KELI -101 on complete or partial recovery and non-recovery of AKI/AKD
Time frame: From baseline to Day 90
Ratio of CKD severity as per eGFR and albuminuria at Day 90
To assess the effect of KELI -101 on sustained decline in renal function
Time frame: Day 90
For matched control cohort: Increased uNGAL and uNGAL/Cr in patients that develop AKI
To assess the magnitude of Increased uNGAL and uNGAL/Cr values in urine in patients that develop AKI as compared to those without developed AKI (21 patients for AKI patients and 10 non-AKI patients' cohorts)
Time frame: Timepoints of 3 Pre-CPB (D-30, D-10 to D-3 and D-1) and 5 (6) after CPB initiation: (CPB-H2, CPB-H3-4, CPB-H5-6, CPB-H9-12, (CPB-H24), and one immediately post-CPB time point (+5 to 15 min), optional
For matched control cohort: Prognostic value of increased uNGAL and uNGAL/Cr, duration, and area under curve in patients that develop AKI as compared to patients that do not develop AKI
To assess the magnitude of Increased uNGAL and uNGAL/Cr values, duration, and area under curve in patients that develop AKI as compared to those without developed AKI (21 patients for AKI patients and 10 non-AKI patients' cohorts)
Time frame: Timepoints of 3 Pre-CPB (D-30, D-10 to D-3 and D-1) and 5 (6) after CPB initiation: (CPB-H2, CPB-H3-4, CPB-H5-6, CPB-H9-12, (CPB-H24), and one immediately post-CPB time point (+5 to 15 min), optional
Ratio of the acute kidney disease (AKD) at Day 10 leading to chronic kidney disease (CKD) at Day 90
To assess the effect of KELI -101 on AKD leading to CKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Time frame: From baseline to Day 90
Ratio of incidence and duration of RRT Day 28
To assess the effect of KELI -101 on incidence and duration of RRT
Time frame: From baseline to Day 28
Occurrence of major adverse kidney event at Day 90 (MAKE90)
To assess the effect of KELI -101 on the incidence of AKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Time frame: Day 90
Occurrence of major adverse kidney event at Day 30 (MAKE30)
To assess the effect of KELI -101 on the incidence of AKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Time frame: Day 28+2 (Phone call)
Occurrence of individual components of the MAKE criteria at Days 30 or 90
To assess the effect of KELI -101 on the incidence of AKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Time frame: Day 28+2 (Phone call)
Occurrence of individual components of the MARCE criteria at Days 7/10/30/90
To assess the effect of KELI -101 on the incidence of AKD in high-risk patients undergoing major cardio-vascular surgery, versus placebo
Time frame: From Day 7 to Day 90
CKD severity as per eGFR and albuminuria at Day 90
To assess the effect of KELI -101 on sustained decline in renal function
Time frame: Day 90
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