Panel Discussion: How Can We Harness Hierarchal Composite Endpoints to Advance CKD Drug Design?
9:30 am - Tuesday 17th March 2026
- The new Kidney HCE framework combines GFR slope, various thresholds of GFR decline (e.g. ≥ 40%, 50%, 57%), ESKD, and mortality in a hierarchical ordering to improve trial sensitivity and clinical relevance
- Regulatory bodies (NKF/FDA/EMA) are increasingly recognizing eGFR slope + albuminuria as valid surrogates, but the choice of thresholds, population, and follow-up duration remain critical
- Key methodological challenges include deciding component priorities, handling multiplicity, ensuring interpretability for patients
- Use-cases in broad CKD and rare subpopulations (e.g. IgA nephropathy) differ: design of HCEs must adapt thresholds, endpoints composition, and regulatory acceptability depending on disease, severity, and existing therapies
