FDA issues letter of support for TKV as ADPKD biomarker

The U.S. Food and Drug Administration (FDA) has issued a Letter of Support to the Critical Path Institute’s (C-Path) Polycystic Kidney Disease Outcomes Consortium (PKDOC) for the use of total kidney volume (TKV) as a prognostic biomarker for clinical trials of new therapies for ADPKD.

The Foundation’s Chief Scientific Officer David Baron explains, “This is important because it shows that the FDA acknowledges variances in the disease progression of ADPKD patients. It means we are increasing the possibility to be able to treat PKD earlier, at a time when treatments can be more effective, rather than after major damage to the kidneys has already occurred.”

TKV is a measurement of the impact of ADPKD on the size of the kidneys and is believed to be an indicator of future kidney function decline. There is no current accepted measure of kidney function that is an accurate marker of disease progression in ADPKD.

PKDOC is a collaboration between the PKD Foundation (the primary funder), C-Path, members of the pharmaceutical industry, PKD researchers and clinicians, and the FDA.