Status: Not yet recruiting
Phase 1B/2 Clinical Trial Assessing the Safety, Tolerability and Preliminary Efficacy of the Intravenous Administration of Allogeneic Placental Mesenchymal Cells for the Preemptive Treatment of Patients At Risk for Acute Kidney Injury Following Cardiac Surgery
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.
Participants needed: 91
Trial details
Phase: Phase 1, Phase 2Age: 45+Biological sex: AllType: InterventionalSponsor: KelifarmaUpdated: Nov 7, 2024
Eligibility criteria
Age ≥ 45 years at screening. [+12]
eGFR at screening <30 mL/min/1.73 m2 (calculated using CKD-EPI 2021 equation), o... [+24]