Data on Clinical Trial End Points for Primary Hyperoxaluria Published
A joint study by the Kidney Health Initiative (KHI), in partnership with the Oxalosis and Hyperoxaluria Foundation (OHF) evaluated efficacy end points for clinical trials in primary hyperoxaluria. The results were published in CJASN.
A literature review and evaluation of potential clinical and surrogate end points was undertaken by the collaborative group. They concluded that marked changes in urine oxalate in CKD stages 1-3a and plasma oxalate in CKD stages 3b-5 can be used as surrogate end points for clinical trials in primary hyperoxaluria.
Although worsening kidney function was deemed an acceptable clinical trial endpoint, the authors noted that rapid kidney function loss is not usually noted in patients with primary hyperoxaluria until very advanced stages of disease.
Read the full report here.
Milliner DS, McGregor TL, Thompson A, et al. Endpoints for clinical trials in rimary hyperoxaluria. CJSAN. 2020; 13821119; DOI: https://doi.org/10.2215/CJN.13821119