Balancing eGFR Decline & TKV Growth for Regulatory Endpoints in PKD
- Evaluating whether TKV growth meets regulatory standards for “reasonably likely surrogate” endpoints, especially under accelerated approval pathways
- Investigating how well eGFR decline tracks patient-centered outcomes and long-term kidney failure risk compared to TKV alone
- Discussing whether combined endpoints (e.g. TKV + eGFR) offer stronger case for full approval versus accelerated or conditional approvals
- Understanding global regulatory differences (FDA, EMA, PMDA etc.) in accepting imaging- and biomarker-based endpoints, and how trials can harmonize design across jurisdictions