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# Guidance on Total Kidney Volume Biomarker
- URL: https://www.fdaweb.com/guidance-on-total-kidney-volume-biomarker-2/
- Published: 2016-09-16T12:00:00.000Z
- Updated: 2026-09-14T21:32:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136831

*Federal Register* Notice: FDA is making available a guidance on “Qualification of Biomarker — Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.” The document provides a qualified context of use for total kidney volume, measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease at high risk for a progressive decline in renal function. The document also describes the experimental conditions and constraints for which this biomarker is qualified through CDER’s Biomarker Qualification Program. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458483.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-09-16/pdf/2016-22347.pdf?ref=fdaweb.com).