Hiddo Lambers Heerspink

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

Charting the Future of CKD Care with Multi-Drug Combinations: One Size Fits All or One Fit for Each?

8:30 am

Evaluating whether all patients require the full suite of therapies or tailored combinations based on individual risk and disease drivers
Defining optimal sequencing strategies: RAS inhibition first, or starting with the most effective therapy for each patient?
Exploring how combination regimens of 3+ drugs can be sequenced and optimized to balance efficacy, safety, and real-world practicality
Considering how obesity, cardiorenal pathophysiology, and kidney structural injury inform future pharmacotherapy strategies

Tuesday 17th March 2026

CAPTIVATE: Innovating Adaptive Platform Trial Design to Slow CKD Progression

12:00 pm

Employing the Global Kidney Patient Trials Network (GKPTN) registry to pre-identify and enroll over 4,300 non-dialysis CKD patients across 8 countries, enabling more representative baseline data
Using an adaptive platform, multifactorial, phase III trial structure allowing addition/removal of therapeutic agents and domains – starting with a mineralocorticoid receptor antagonist vs placebo
Targeting slowing of eGFR decline as the primary endpoint, powered via Bayesian simulations
Building in flexibility through the “eternal” trial design (ongoing recruitment and follow-up), enabling testing of combination treatments and evolving interventions over time