Balancing eGFR Decline & TKV Growth for Regulatory Endpoints in PKD
- Explore the manner of disease progression of ADPKD Evaluating whether TKV growth meets regulatory standards for “reasonably likely surrogate” endpoints, especially underaccelerated 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