EPO-4-Rhesus Study
EPO-4-Rhesus
Randomized Controlled Trial on the Use of EPO to Reduce Top-up Transfusions in Neonates With Red Blood Cell Alloimmunization Treated With Intrauterine Transfusions
1 other identifier
interventional
42
1 country
1
Brief Summary
Up to 80% of infants with hemolytic disease due to maternal alloimmunization, treated with IUT, require at least one top-up transfusion for late anemia during the first 3 months of life. Erythropoietin deficiency is also considered as a possible contributing factor to late anemia and therefore we will assess the role of EPO (darbepoetin alfa) in the treatment of these infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedStudy Start
First participant enrolled
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedOctober 2, 2019
September 1, 2019
2.8 years
April 3, 2017
September 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of top-up transfusions required per infant
Number of top-up transfusions required per infant
First 3 months of life
Secondary Outcomes (4)
The percentage of infants requiring a top-up transfusion
First 3 months of life
Number of days of admission for top-up transfusions
First 3 months of life
Occurrence of hypertension
8 weeks (treatment course)
Occurrence of high ferritin levels
8 weeks (treatment course)
Other Outcomes (1)
Long-term neurodevelopmental outcome
2 years of age
Study Arms (2)
Darbepoetin alfa group
ACTIVE COMPARATORGroup treated with darbepoetin alfa (Aranesp) 10microg/kg once a week for a period of 8 weeks.
Control group
NO INTERVENTION"Standard care" which involves close monitoring of hemoglobin levels and if necessary, top-up red cell transfusion.
Interventions
Darbepoetin alfa dosage 10microg/kg once a week for 8 weeks
Eligibility Criteria
You may qualify if:
- all (near)-term neonates (gestational age ≥ 35 weeks) admitted to the Leiden University Medical Center (LUMC) with HDFN, treated with IUT.
You may not qualify if:
- none.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leiden University Medical Center
Leiden, 2300RC, Netherlands
Related Publications (1)
Ree IMC, de Haas M, van Geloven N, Juul SE, de Winter D, Verweij EJT, Oepkes D, van der Bom JG, Lopriore E. Darbepoetin alfa to reduce transfusion episodes in infants with haemolytic disease of the fetus and newborn who are treated with intrauterine transfusions in the Netherlands: an open-label, single-centre, phase 2, randomised, controlled trial. Lancet Haematol. 2023 Dec;10(12):e976-e984. doi: 10.1016/S2352-3026(23)00285-5.
PMID: 38030319DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Masja de Haas, MD PhD
Sanquin Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 7, 2017
Study Start
October 31, 2017
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
October 2, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share