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nedosiran · 1 trial · 4 indications
This outcome measure reported percent change from baseline to Month 6 in spot urinary oxalate-to-creatinine ratio in pediatric participants (birth to 11 years of age) with genetically confirmed primary hyperoxaluria type 1 (PH1), primary hyperoxaluria type 2 (PH2), or primary hyperoxaluria type 3 (PH3) subgroups.
This outcome measure reported absolute change from baseline to Month 6 in spot urinary oxalate-to-creatinine ratio in pediatric participants (birth to 11 years of age) with genetically confirmed PH1, PH2, or PH3 subgroups.
| Arm | Type | Description |
|---|---|---|
| Open-Label DCR-PHXC | EXPERIMENTAL | Open-Label monthly subcutaneous injection of DCR-PHXC based on age and weight. |
| Name | Type | Description |
|---|---|---|
| nedosiran | DRUG | Monthly subcutaneous dosing throughout study period |
Inclusion Criteria: 1. Birth to 11 years of age inclusive, at the time of signing the informed consent. 2. Documented diagnosis of PH1 or PH2 or PH3 confirmed by genotyping (historically available genotype information is acceptable for study eligibility). 3. Average spot Uox to creatinine ratio at ...
Nedosiran is an investigational small molecule being developed for the treatment of Primary Hyperoxaluria, a rare inherited disorder that leads to excessive oxalate production and kidney stone formation. It is being studied across Primary Hyperoxaluria Types 1, 2, and 3.
Nedosiran is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO.
Nedosiran is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities.
Nedosiran has one completed Phase 2 clinical trial, identified as NCT05001269. This trial studied nedosiran in pediatric patients from birth to 11 years of age with Primary Hyperoxaluria and relatively intact renal function, enrolling 27 participants.
Yes, nedosiran has been studied in a Phase 2 clinical trial that enrolled pediatric patients from birth to 11 years of age with Primary Hyperoxaluria. The trial included participants with Primary Hyperoxaluria Types 1, 2, and 3.