DCR-PHXC for Kidney Failure

(PHYOX7 Trial)

Recruiting at12 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Dicerna Pharmaceuticals, Inc.

Must not be taking: RNAi drugs

Disqualifiers: Hepatic transplant, Severe oxalosis, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called DCR-PHXC for people with severe kidney disease (PH1 or PH2). The treatment aims to protect the kidneys and improve their function. Participants will receive the medication over a period of time, with an option for continued monitoring.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

You have a positive anti-dsDNA antibody test result.

Inability or unwillingness to comply with the specified study procedures, including the lifestyle considerations

You have had serious reactions to a specific type of therapy using oligonucleotides.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 5 weeks

Treatment

Participants receive monthly subcutaneous injections of DCR-PHXC based on age and weight

6 months

6 visits (monthly, in-person)

Extended Follow-up

Participants continue to receive open-label DCR-PHXC for an additional 5 years or until commercially available

Up to 5 years

Quarterly visits (in-person), with potential at-home administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DCR-PHXC (RNAi Therapeutics)

Trial Overview 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.

Participant Groups

Group I: Open-Label DCR-PHXC Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Dicerna Pharmaceuticals, Inc.

Lead Sponsor

Trials

15

Recruited

500+

Founded

2007

Headquarters

Watertown, USA

Known For

RNA Therapeutics

Top Products

GalXC, GalXC-Plus

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Lead Sponsor

Trials

19

Recruited

580+