drugset / Trial / NCT06678399

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

NCT06678399 ↗

Phase 1/2 Not yet recruiting 91 enrolled Kelifarma
RandomizedSingle-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2025-04-01
Primary completion
2026-10-01
Completion
2027-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject KELI-101 Cell therapy — Intravenous

Indications

No indication recorded.