Public Release Type:
Conference Presentation
Publication Year: 2023
Affiliation: 1 Critical Path Institute, Tucson, AZ; 2 Sanofi, Cambridge, MA; 3 Tufts Medical Center, Boston MA
Authors:
Leiser R,
Cui Z,
Aggarwal V,
Romero K,
Quinlan L,
Miller C,
Vanasco W,
Fedeles S,
Perrone R,
Zaph S,
DasMahapatra P,
Morales JF
Request IDs:
22905
Studies:
Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease
,
The HALT Progression of Polycystic Kidney Disease
Despite the regulatory advances in ADPKD including the qualification of total kidney volume (TKV) as a prognostic enrichment biomarker and its designation by the FDA as a reasonably likely surrogate endpoint, the clinical development paradigms for PKD remain challenging. This highlights the need to quantify the time course of renal decline and disease progression patterns and their sources of variability to facilitate the development of novel therapies.