Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• Nedosiran significantly reduced 24-hour urinary oxalate (UOX) excretion, with an area under the curve (AUC) of +3507 with a standard error (SE) of 788 in the nedosiran group compared to -1664 with a SE of 1190 in the placebo group, resulting in a difference of 5172 with 95% confidence interval (CI) of 2929 to 7414 (P < 0.001).
• In the Primary Hyperoxaluria Type 1 (PH1) subgroup, 64.7% achieved normal or near-normal Uox excretion on ≥2 consecutive visits starting at day 90, while 0% in the placebo group achieved this outcome (P < 0.001), indicating a favorable response to nedosiran.
• The Primary Hyperoxaluria Type 2 (PH2) subgroup did not demonstrate a consistent reduction in Uox, suggesting a less favorable or variable response to nedosiran.
• Nedosiran was generally safe and well tolerated, with injection-site reactions occurring in 9% of participants, all of which were mild and self-limiting.
• The safety profile of nedosiran indicates manageable adverse effects, with no significant safety concerns reported beyond the mild injection-site reactions.
• There is no population types or subgroups information available in the reviewed documents.