Dustin Little
Global Clinical Lead AstraZeneca
Seminars
Tuesday 17th March 2026
Chair’s Opening Remarks
7:55 am
Tuesday 17th March 2026
Panel Discussion: How Can We Harness Hierarchal Composite Endpoints to Advance CKD Drug Design?
9:30 am
- 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
Tuesday 17th March 2026
Track Chair:
Tuesday 17th March 2026
Leveraging Hierarchical Composite Endpoints to Capture Meaningful Outcomes in CKD Trials
2:00 pm
- Defining the role of hierarchical endpoints in addressing heterogeneity in CKDoutcomes
- Designing trials that balance regulatory rigor with clinical relevance
- Case examples of composite endpoint application in recent CKD studies
- Best practices and pitfalls when perationalizing hierarchical outcome measures
Tuesday 17th March 2026
Chair’s Closing Remarks
6:15 pm
