Primary hyperoxaluria and enteric hyperoxaluria are rare disorders that cause frequent kidney stones, nephrocalcinosis, and kidney failure. Promising new treatments are emerging to manipulate oxalate biosynthesis and absorption from the gastrointestinal tract. Careful evaluation of their effectiveness is essential for successful implementation. There has not been accepted endpoints to evaluate new therapeutic agents.

The Kidney Health Initiative convened two projects to evaluate potential biochemical endpoints for use to establish efficacy of agents to treat hyperoxaluria to expedite their approval. These projects included patients, families, advocacy organizations (Oxalosis and Hyperoxaluria Foundation), clinicians, scientists, pharmaceutical companies, and the US Food and Drug Administration (FDA). Their work culminated in the authorship of the publications below that summarize the consensus assessments.