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NCT05340465 · ClinicalTrials.gov registry record · Phase 2
Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
A Phase 2 study of Iron Deficiency Anemia and Prematurity, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05340465 is a Phase 2 study of Iron Deficiency Anemia and Prematurity that is actively recruiting participants, run by University of Washington. The registered enrollment target is 120 participants, below the 189-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05340465, a Phase 2 study of Iron Deficiency Anemia and Prematurity, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency and improve the neurodevelopmental outcomes of preterm infants. Investigators hypothesize that in infants \< 32 completed weeks of gestation, combined treatment with Darbe plus Ferumoxytol (FMX) or Darbe plus low molecular weight iron dextran (LMW-ID) will: 1) be safe, 2) decrease or eliminate transfusions, 3) maintain iron sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. Investigators further hypothesize that when compared to oral iron supplementation (standard care), IV iron will be better tolerated, with less effect on the gastrointestinal (GI) microbiome
Conditions Studied
Interventions
- DRUG Darbepoetin Alfa
- DRUG Low Molecular Weight Iron Dextran
- DRUG Ferumoxytol injection
- DRUG Oral iron supplements
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-11-27 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05340465
The ClinicalTrials.gov registry entry for NCT05340465 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 189-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (37% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 4 interventions - of which Darbepoetin Alfa is the first listed.
NCT05340465 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT05340465 about?
NCT05340465 is a clinical study titled "Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants". In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency and improve the neurodevelopmental outcomes of preterm infants. Inves...
What is the current status of trial NCT05340465?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2022-11-27. Estimated completion is 2027-06-30.
What conditions does trial NCT05340465 study?
This clinical trial studies the following conditions: Iron Deficiency Anemia, Prematurity, Iron-deficiency, Iron Malabsorption.
What interventions are being tested in trial NCT05340465?
The interventions under investigation include: Darbepoetin Alfa (DRUG), Low Molecular Weight Iron Dextran (DRUG), Ferumoxytol injection (DRUG), Oral iron supplements (DRUG).
Who is sponsoring clinical trial NCT05340465?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05340465 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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