Your session is about to expire
← Back to Search
RNAi Therapeutics
Long-Term DCR-PHXC Treatment for Primary Hyperoxaluria (PHYOX3 Trial)
Phase 3
Waitlist Available
Research Sponsored by Dicerna Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Estimated GFR at screening ≥ 30 mL/min normalized to 1.73 m2 body surface area (BSA), calculated using appropriate formula based on age and region
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly for 4 months (d90 through d180)
Awards & highlights
PHYOX3 Trial Summary
This trial will allow kids who have participated in earlier trials for a PH treatment to have long-term access to the treatment, and to study the long-term safety and effectiveness of the treatment.
Who is the study for?
This trial is for patients with a genetic kidney condition called Primary Hyperoxaluria who completed previous DCR-PHXC studies, and their siblings under 18 with the same condition. Participants must have a certain level of kidney function and not be on dialysis or have had a kidney or liver transplant.Check my eligibility
What is being tested?
The study provides long-term access to DCR-PHXC for those previously enrolled in early-phase trials. It aims to assess the extended safety and effectiveness of this drug in treating Primary Hyperoxaluria.See study design
What are the potential side effects?
While specific side effects are not listed here, they may include typical reactions to medication such as injection site discomfort, potential liver or kidney-related issues due to the nature of the disease being treated, and other common drug-related adverse events.
PHYOX3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is adequate based on a test result.
PHYOX3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ monthly for 4 months (d90 through d180)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly for 4 months (d90 through d180)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The annual rate of decline in eGFR in participants with PH1
Secondary outcome measures
Change from Baseline in the EQ-5D-5L™ in adults in PH1, PH2, and PH3 participant subgroups
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL™) in children in PH1, PH2, and PH3 participant subgroups
Philadelphia Chromosome
+13 moreOther outcome measures
To characterize the PK of DCR PHXC in patients with PH by observing clearance.
To characterize the PK of DCR PHXC in patients with PH by observing maximum concentration (Tmax).
To characterize the PK of DCR PHXC in patients with PH by observing maximum observed concentration (Cmax).
+5 morePHYOX3 Trial Design
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Open label, monthly subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DCR-PHXC
2019
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Dicerna Pharmaceuticals, Inc.Lead Sponsor
14 Previous Clinical Trials
442 Total Patients Enrolled
2 Trials studying Primary Hyperoxaluria
68 Patients Enrolled for Primary Hyperoxaluria
Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyLead Sponsor
17 Previous Clinical Trials
490 Total Patients Enrolled
2 Trials studying Primary Hyperoxaluria
68 Patients Enrolled for Primary Hyperoxaluria
Verity Rawson, MB.CHBStudy DirectorDicerna, A Novo Nordisk Company
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have already finished a Dicerna Pharmaceuticals, Inc. study of DCR PHXC.My sibling completed a Dicerna study for DCR PHXC, I'm under 18, and have confirmed PH.My kidney function is adequate based on a test result.I have symptoms of systemic oxalosis.I am currently receiving dialysis.Your plasma oxalate level is higher than 30 µmol/L.I have had or am planning to have a kidney or liver transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary aim of this clinical trial?
"The primary outcome of this study is to monitor the annual change in eGFR in participants with PH1. Secondary objectives include evaluating the safety and tolerability of DCR PHXC via change from baseline in TEAEs and SAEs associated with abnormal 12 lead electrocardiogram readings and abnormal vital signs, as well as assessing the effect of DCR-PHXC on stone burden in patients with PH."
Answered by AI
Are people who meet the requirements able to sign up for this experiment right now?
"The clinical trial listed on clinicaltrials.gov is not recruiting patients at this time. This particular study was posted on July 9th, 2019 and was last edited on June 22nd, 2020. Although this study isn't looking for patients right now, there are 569 other studies that are."
Answered by AI
Has the FDA cleared DCR-PHXC for therapeutic use?
"There is some evidence, from multiple sources, that DCR-PHXC is effective and safe."
Answered by AI
How many health care facilities are administering this experiment?
"Currently, this study is being conducted at 5 different sites. They are situated in Boston, Hamilton and Rochester, as well as 5 other places. If you are considering participating, please choose the site that is most convenient for you to limit travel time and hassle."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger