Acute Kidney Injury (AKI) is a major complication in acutely ill, hospitalized patients and those undergoing cardiac surgery (CS) requiring cardiopulmonary bypass. Progress in therapeutic development is hampered by a lack of agreed upon biomarkers, intermediate, surrogate, and clinical endpoints. For this document, a biomarker is defined as a measurable indicator of kidney stress or injury, an intermediate endpoint is an outcome on the causal pathway to clinically meaningful endpoints, and a surrogate endpoint is a measure that regulators accept as predicting clinically meaningful outcomes.

This project seeks to accelerate progress in CS-AKI therapeutic development by convening key partners to identify promising trial endpoints in phase 2 proof-of-concept (POC) and phase 3 clinical trials.

The Kidney Health Initiative (KHI) will conduct a workshop with experts from academia, industry, professional societies, patient advocacy groups, the National Institutes of Health (NIH), the Critical Path Institute (C-Path), and the Food and Drug Administration (FDA) to build alignment on priority areas. The workshop will explore opportunities to:

• Identify and prioritize biomarkers predictive of long-term outcomes following CS-AKI
• Define intermediate endpoints appropriate for proof-of-concept studies
• Define surrogate and clinical endpoints appropriate for confirmatory studies
• Establish consensus on standardized data collection and trial design elements
• Outline pathways toward approvable endpoints that reflect meaningful patient benefit beyond current measures such as major adverse kidney events (MAKE)

The goal is to provide a clear roadmap for next steps that can guide clinical development and regulatory evaluation. Deliverables will include a workshop proceedings document summarizing identified gaps, challenges, and proposed next steps for advancing therapeutic innovation in CS-AKI.

A kick-off meeting is envisioned by the end of 2025.