Dustin Little
Global Clinical Lead AstraZeneca
Seminars
Tuesday 17th March 2026
Track Chair:
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
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 Opening Remarks
7:55 am
Tuesday 17th March 2026
Chair’s Closing Remarks
6:15 pm
