Clinical Trials Logo
  1. Home
  2. Primary Hyperoxaluria
  3. NCT05001269

Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function — PHYOX8  

Primary Hyperoxaluria Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05001269
Study type Interventional
Source Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Contact Medical Information
Phone 617-621-8097
Email medicalinfo@dicerna.com
Status Recruiting
Phase Phase 2
Start date February 22, 2022
Completion date December 2024
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT00875823 - International Registry for Primary Hyperoxaluria N/A
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Completed NCT02340689 - Primary Hyperoxaluria Mutation Genotyping/Phenotyping
Completed NCT00638703 - Study to Evaluate the Efficacy and Safety of OxabactTM on Reduction of Urinary Oxalate in Primary Hyperoxaluria Patients Phase 2/Phase 3
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Completed NCT03819647 - Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria Phase 2
Recruiting NCT02026388 - Rare Kidney Stone Consortium Biobank
Completed NCT02000219 - Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis Phase 2
Recruiting NCT05843851 - Genetic Newborn Screening for Cystinosis and Primary Hyperoxaluria N/A
Recruiting NCT00588562 - Rare Kidney Stone Consortium Patient Registry
Completed NCT03391804 - Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia Phase 2
Completed NCT03116685 - A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria Phase 3
Recruiting NCT05107830 - Phenotyping of Primary Hyperoxaluria
Active, not recruiting NCT04152200 - A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 Phase 3
Completed NCT03392896 - Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria Phase 1
Completed NCT02012985 - Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria Phase 1/Phase 2
Completed NCT01037231 - Phase 2/3 Oxabact Study Phase 2/Phase 3
Completed NCT00589225 - Primary Hyperoxaluria Mutation Genotyping Phase 1
Completed NCT02124395 - Health-related Quality of Life in Rare Kidney Stone
Completed NCT03350451 - An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1 Phase 2