Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD

Part of paid clinical trials in San Francisco, California.

Sponsor
Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Study ID
NCT04580420
Phase
PHASE2
Status
Recruiting
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Conditions

  • End Stage Renal Disease
  • Primary Hyperoxaluria Type 1

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • DCR-PHXC — DRUG
    Monthly dosing throughout study period

Study Details

The aim of this study is to evaluate DCR-PHXC in participants with PH1 and severe renal impairment, with or without dialysis.

Key Dates

Start date
Apr 15, 2021
Status verified
Dec 2025
Primary completion
Dec 30, 2031
Completion
Jan 30, 2032

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Safety: Incidence of Events [ Time Frame: 180 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Trial SiteSan FranciscoCalifornia94143-
Clinical Trial SiteBostonMassachusetts02115-
Clinical Trial SiteRochesterMinnesota55905
Clinical Trial Coordinator
Clinical Trial SiteNew YorkNew York10016-

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