← Back to Search

RNAi Therapeutics

nedosiran for Primary Hyperoxaluria (PHYOX8 Trial)

Phase 2

Recruiting

Research Sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

PHYOX8 Trial Summary

This trial will study the effects of nedosiran in children with Primary Hyperoxaluria, a kidney disease.

Who is the study for?

This trial is for children from birth to 11 years with Primary Hyperoxaluria (PH), a genetic disorder affecting the kidneys, who have normal or near-normal kidney function. Participants need a legal guardian to consent and help with study requirements, must not be pregnant or breastfeeding if applicable, and should be on stable PH treatment for at least 3 months.Check my eligibility

What is being tested?

The trial is testing nedosiran, a medication intended to treat Primary Hyperoxaluria in young patients. It aims to evaluate its effectiveness and safety in those who still have relatively good kidney function.See study design

What are the potential side effects?

While specific side effects of nedosiran are not listed here, similar drugs can cause reactions like flu-like symptoms, liver issues indicated by blood tests changes, severe skin reactions at injection sites, and potential allergic responses.

PHYOX8 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy: Absolute change in urinary oxalate to creatinine ratio

Efficacy: Percent change in urinary oxalate to creatinine ratio

Secondary outcome measures

Efficacy: eGFR changes

Safety: Changes from baseline in ECG: PR interval

Safety: Changes from baseline in ECG: QRS duration

+21 more

Other outcome measures

Change from Baseline in Plasma Oxalate Concentration

Change from Baseline number of kidney stones

Change from baseline PedsQL™

+1 more

PHYOX8 Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-Label DCR-PHXCExperimental Treatment1 Intervention

Open-Label monthly subcutaneous injection of DCR-PHXC based on age and weight.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyLead Sponsor

17 Previous Clinical Trials

540 Total Patients Enrolled

1 Trials studying Primary Hyperoxaluria

43 Patients Enrolled for Primary Hyperoxaluria

Dicerna Pharmaceuticals, Inc.Lead Sponsor

14 Previous Clinical Trials

492 Total Patients Enrolled

1 Trials studying Primary Hyperoxaluria

43 Patients Enrolled for Primary Hyperoxaluria

Alexandra Haagensen, MD, MBAStudy ChairDicerna Pharmaceuticals, Inc.

3 Previous Clinical Trials

33 Total Patients Enrolled

Media Library

nedosiran (RNAi Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT05001269 — Phase 2

Primary Hyperoxaluria Research Study Groups: Open-Label DCR-PHXC

Primary Hyperoxaluria Clinical Trial 2023: nedosiran Highlights & Side Effects. Trial Name: NCT05001269 — Phase 2

nedosiran (RNAi Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05001269 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can potentially join this trial?

"Affirmative, the information available on clinicaltrials.gov indicates that this study is still in progress. Initially posted on February 22nd 2022 and recently modified on November 30th 2022, it aims to recruit 20 people from 3 different medical centres."

Answered by AI

To what extent is nedosiran hazardous to human health?

"Nedosiran has been assigned a score of 2, as there is evidence to suggest it is safe but no clinical trials have yet tested its efficacy."

Answered by AI

What are the primary aims of this clinical research project?

"This clinical trial is scheduled to last for 180 days and will measure the efficacy of a particular medical intervention via % change in urinary oxalate-creatinine ratio. Secondary goals include characterizing safety using changes from baseline in laboratory tests, blood pressure readings, and individual pharmacokinetic parameters (AUC)."

Answered by AI

Are there still opportunities for applicants to join this medical experiment?

"Affirmative. The information on clinicaltrials.gov reveals that the trial is actively seeking participants; this study, which was initially posted on February 22nd 2022, has been recently modified as of November 30th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05001269.