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RNAi Therapeutics
DCR-PHXC for Kidney Failure (PHYOX7 Trial)
Phase 2
Recruiting
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 <30mL/min normalized to 1.73m^2 BSA
Documented diagnosis of PH1 or PH2, confirmed by genotyping
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
PHYOX7 Trial Summary
This trial is testing a new treatment for people with severe kidney problems caused by PH1 or PH2.
Who is the study for?
This trial is for individuals with Primary Hyperoxaluria (PH1 or PH2) and severe kidney impairment, who may or may not be on dialysis. Participants must have a certain body weight, provide consent, have health insurance if required by law, and meet specific genetic diagnosis and plasma oxalate levels. There are age-specific groups from newborns to adults. Those on dialysis should have been stable for at least 2 weeks.Check my eligibility
What is being tested?
The study tests DCR-PHXC in patients with PH1/2 who also suffer from end-stage renal disease (ESRD). It aims to assess the safety and effectiveness of this intervention in improving their condition regardless of whether they're undergoing dialysis treatment.See study design
What are the potential side effects?
Potential side effects include reactions related to oligonucleotide-based therapies which could involve immune responses like inflammation or sensitivity issues due to ingredients in DCR-PHXC. Specific side effect profiles will be monitored throughout the trial.
PHYOX7 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is severely reduced.
Select...
My diagnosis of PH1 or PH2 is confirmed by genetic testing.
PHYOX7 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: Incidence of Events
Secondary outcome measures
Change from Baseline in Plasma Oxalate Concentration
Change in Duration of Dialysis
Change in Frequency of Dialysis
+5 moreOther outcome measures
Change from Baseline in the EQ-5D-5L™ in adults
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL™) in children
Change from Baseline in the Short Form (36) Health Survey (SF-36®) in adults
+2 morePHYOX7 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.
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
500 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
548 Total Patients Enrolled
2 Trials studying Primary Hyperoxaluria
68 Patients Enrolled for Primary Hyperoxaluria
Alexandra Haagensen, MD, MBAStudy ChairDicerna Pharmaceuticals, Inc.
3 Previous Clinical Trials
41 Total Patients Enrolled
1 Trials studying Primary Hyperoxaluria
25 Patients Enrolled for Primary Hyperoxaluria
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a positive anti-dsDNA antibody test result.I can sign the consent form myself, or my guardian can if I'm a minor.My weight fits the required range for my age group.My kidney function is severely reduced.You have had serious reactions to a specific type of therapy using oligonucleotides.I do not have any health conditions that would affect my participation in the study.My liver tests are higher than normal for my age and gender.My diagnosis of PH1 or PH2 is confirmed by genetic testing.You have consumed a lot of alcohol in the 2 years before joining the study.I am a teenager able to give written agreement to participate.I am in one of the specified age groups: adult, adolescent, child, or infant.I have been on dialysis for less than 18 months and my treatment has been stable for the last 2 weeks.Your average plasma oxalate level is higher than 20μmol/L during screening.You have severe symptoms of oxalosis throughout your body.I have had a liver transplant or will have one soon. Kidney transplants are okay.I am either male or female.You are allergic to DCR-PHXC or any of its ingredients.I have not used any RNAi drugs other than DCR-PHXC in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Open-Label DCR-PHXC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 total sample size of this clinical research?
"Affirmative. Clinicaltrials.gov has registered that this clinical trial is currently open for participants, having first been posted on April 15th 2021 and last edited November 14th 2022. The study necessitates the recruitment of 17 patients from two distinct locations."
Answered by AI
Is enrollment currently available for this research initiative?
"According to clinicaltrials.gov, this medical study is actively searching for volunteers, with the trial first becoming available on April 15th 2021 and revised most recently on November 14th 2022."
Answered by AI
What potential hazards are associated with DCR-PHXC treatments?
"The safety of this investigational drug, DCR-PHXC, is estimated to be a 2 on our scale due to the lack of supporting efficacy data that accompanies Phase 2 clinical trials."
Answered by AI
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