Hiddo Heerspink

Wednesday 18th March 2026

Panel Discussion: Who Are the High-Risk CKD Patients Now? Redefining Risk Beyond Proteinuria

4:30 pm

Understanding what is the unmet need on top of standard of care and treatment landscape Combinations & Polypharmacy?
Are traditional definitions of high risk (low eGFR, proteinuria) still sufficient in the era of multi-omics and cardiometabolic overlap?
What biomarkers and surrogate endpoints are emerging to identify and serve non-proteinuric CKD patients?
How can we define clinical endophenotypes, such as patients with reduced ejection fraction, diabetes, or obesity—that may signal higher risk or non-response?
What data are missing from current longitudinal cohorts (e.g., cardiovascular outcomes, repeat biopsies), and how do we fill these gaps to better guide drug development?

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 + clinical endpoints 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 & payers, and choosing proper statistical methods (win-odds, hierarchical ranking) to avoid bias
Use-cases in broad CKD and rare subpopulations (e.g. IgA nephropathy, PKD) 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 to detect a clinically meaningful improvement of ~2.6 mL/min/1.73 m² over 104 weeks
Building in flexibility through the “eternal” trial design (ongoing recruitment and follow-up), enabling testing of combination treatments and evolving interventions over time