Group 2 for Iron-deficiency

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Washington, Seattle, WA
Iron-deficiency+6 More
Darbepoetin Alfa - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
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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

Eligible Conditions

  • Iron-deficiency
  • Infants, Premature
  • Iron Deficiency Anemia (IDA)
  • Iron Malabsorption

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: at 1 and 2 years corrected age.

Year 2
Neurodevelopmental outcome as assessed by the Bayley Scales of Infant Development edition-IV (BSID-IV)
3 months corrected age
Rate of pass/fail the General Movements Assessments (GMA)
Month 18
Scores for the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be compared between groups
Week 36
Cumulative transfusion volume (mL/kg)
Number and percent of patients per group that remain transfusion free
Rate of anaphylaxis will be compared between treatment groups
Year 2
Late gut microbiome comparison between study groups
Week 4
Early gut microbiome comparison between study groups
Week 36
Rate of referral for Brainstem auditory evoked response
Week 36
Number of doses of IV iron required to maintain serum ferritin > 75 microgram/L will be compared between IV iron groups

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

Group 1. Oral iron
1 of 5
Group 2
1 of 5
Group 3
1 of 5
Group 4
1 of 5
Group 5
1 of 5
Active Control
Experimental Treatment

120 Total Participants · 5 Treatment Groups

Primary Treatment: Group 2 · No Placebo Group · Phase 2

Group 2Experimental Group · 2 Interventions: Darbepoetin Alfa, Low Molecular Weight Iron Dextran · Intervention Types: Drug, Drug
Group 3Experimental Group · 2 Interventions: Darbepoetin Alfa, Low Molecular Weight Iron Dextran · Intervention Types: Drug, Drug
Group 4Experimental Group · 2 Interventions: Darbepoetin Alfa, Ferumoxytol injection · Intervention Types: Drug, Drug
Group 5Experimental Group · 2 Interventions: Darbepoetin Alfa, Ferumoxytol injection · Intervention Types: Drug, Drug
Group 1. Oral iron
Drug
ActiveComparator Group · 1 Intervention: Oral iron supplements · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darbepoetin Alfa
2008
Completed Phase 4
~5950

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 and 2 years corrected age.

Trial Background

Prof. Sandra E Juul,, MD PhD
Principal Investigator
University of Washington
Closest Location: University of Washington · Seattle, WA
Photo of university of washington  1Photo of university of washington  2Photo of university of washington  3
1993First Recorded Clinical Trial
1 TrialsResearching Iron-deficiency
628 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are born at 24-0/7 to 31-6/7 weeks of gestation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.