Kidney Health Initiative Completes Project Focused on Clinical Trial End Points for Primary Hyperoxaluria
American Society of Nephrology (ASN)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.