Tag: Kidney Health Initiative

Available evidence supports the use of marked changes in urine oxalate in CKD stages 1-3a and plasma oxalate in CKD stages 3b-5 as surrogate end points for clinical trials in primary hyperoxaluria.

Worsening kidney function is considered an acceptable clinical trial end point; however in many patients with primary hyperoxaluria, kidney function is not lost at a rapid rate until very advanced stages of disease.

Kidney stones are clinically meaningful, though lack sufficient standards for measurement and monitoring. Their role as a feasible clinical end point should be reconsidered as more data becomes available.