Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 2:42 PM
Study NCT ID:
NCT05001269
Status:
COMPLETED
Last Update Posted:
2025-10-30
First Post:
2021-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function
Sponsor:
Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Organization:
Study Overview
Official Title:
A Phase 2 Open-Label Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Nedosiran in Pediatric Patients From Birth to 11Years of Age With Primary Hyperoxaluria and Relatively Intact Renal Function
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHYOX8
Brief Summary:
The aim of this study is to evaluate nedosiran in participants 11 years of age and younger who have Primary Hyperoxaluria with relatively intact renal function.
Detailed Description:
This is an open-label, repeat-dose, Phase 2 study of nedosiran in participants 11 years of age or younger who have PH1, PH2 or PH 3 and relatively intact renal function.
Following the up-to-35- day screening period, participants will return to the clinic for monthly dosing visits through Day 180.
The total duration of this study is approximately 15 months from first participant, first visit, until last participant, last visit.
Following the up-to-35- day screening period, participants will return to the clinic for monthly dosing visits through Day 180.
The total duration of this study is approximately 15 months from first participant, first visit, until last participant, last visit.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: