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NCT04042402 · ClinicalTrials.gov registry record · Phase 3
Long Term Extension Study in Patients With Primary Hyperoxaluria
A Phase 3 study of Kidney Diseases and Genetic Disease, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.
- Active
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT04042402: Active Phase 3 study of Kidney Diseases and Genetic Disease, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.
NCT04042402 is a Phase 3 study of Kidney Diseases and Genetic Disease that is active but no longer recruiting, run by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company. The registered enrollment target is 75 participants, below the 1,784-participant average among 38 other Kidney Diseases trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04042402, a Phase 3 study of Kidney Diseases and Genetic Disease, is active but no longer recruiting, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
Study Summary
The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (\<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.
Primary Outcome
To evaluate the effect of DCR PHXC on estimated glomerular filtration rate (eGFR) in participants with PH1
Conditions Studied
Interventions
- DRUG DCR-PHXC
Study Locations (20)
Other
- Clinical Trial Site - Melbourne
- Clinical Trial Site - Bron
- Clinical Trial Site - Paris
- Clinical Trial Site - Bonn
- Clinical Trial Site - Heidelberg
- Clinical Research Site - Roma
- Clinical Trial Site - Fukuoka
- Clinical Trial Site - Nagoya
- Clinical Trial Site - Tokyo
- Clinical Trial Site - Beirut
- Clinical Trial Site - Amsterdam
- Clinical Trial Site - Tromsø
- Clinical Research Site - Barcelona
- Clinical Trial Site - Barcelona
California
- Clinical Research Site - San Francisco
Massachusetts
- Clinical Trial Site - Boston
Minnesota
- Clinical Trial Site - Rochester
New York
- Clinical Trial Site - New York
Queensland
- Clinical Research Site - Herston
Ontario
- Clinical Research Site - Hamilton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-07-09 |
| Est. Completion | 2030-04-01 |
| Phase | Phase 3 |
What the registry record for NCT04042402 still lists
NCT04042402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,784-participant average among 38 other Kidney Diseases trials with a reported enrollment target (96% lower).
The record links to 6 conditions, with Kidney Diseases appearing as the primary indexed condition, and to 1 intervention - of which DCR-PHXC is the first listed.
NCT04042402 names 20 study sites across 7 states, led by Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04042402 about?
NCT04042402 is a clinical study titled "Long Term Extension Study in Patients With Primary Hyperoxaluria". The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (\<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.
What is the current status of trial NCT04042402?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2019-07-09. Estimated completion is 2030-04-01.
What conditions does trial NCT04042402 study?
This clinical trial studies the following conditions: Kidney Diseases, Genetic Disease, Urologic Diseases, Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2).
What interventions are being tested in trial NCT04042402?
The interventions under investigation include: DCR-PHXC (DRUG).
Who is sponsoring clinical trial NCT04042402?
This trial is sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04042402 being conducted?
This trial has 20 study locations across California, Massachusetts, Minnesota, New York, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04042402's enrollment target sits among peer trials
75 26th of 38 higher than 13 of 38 other Kidney Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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