EPO-4-Rhesus Study (EPO-4-Rhesus)
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|ClinicalTrials.gov Identifier: NCT03104426|
Recruitment Status : Unknown
Verified September 2019 by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research.
Recruitment status was: Recruiting
First Posted : April 7, 2017
Last Update Posted : October 2, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Erythroblastosis, Fetal Erythroblastosis Fetalis, Rh Disease Erythroblastosis Fetalis Due to RH Antibodies Erythroblastosis Fetalis Due to Isoimmunization||Drug: Darbepoetin Alfa||Phase 2 Phase 3|
The mainstay of antenatal treatment of fetal anemia due to red cell alloimmunization is (serial) IUT. The mainstay of postnatal treatment in HDN is (1) intensive phototherapy and exchange transfusion to treat hyperbilirubinemia and prevent kernicterus, and (2) top-up transfusions to treat anemia. Up to 80% of infants with HDN treated with IUT require at least one top-up transfusion for late anemia during the first 3 months of life.
Several risk factors for late anemia have been reported, including serial IUT (due to bone marrow suppression), severity of HDN, reduced use of exchange transfusions during the neonatal period and reduced survival of transfused red blood cells. Finally, erythropoietin deficiency is also considered as a possible contributing factor to late anemia.
EPO has been increasingly used in neonates to prevent or reduce neonatal anemia without short or long-term adverse effects. Several small studies and casuistic reports suggest that neonates with HDN may benefit from treatment with EPO to reduce the risk of delayed anemia and subsequent top-up transfusions. However, other authors found that EPO may be less effective than expected. Due to the lack of evidence, routine use of EPO is currently not recommended. To determine a role for EPO in this group of patients, a well-designed randomized controlled clinical trial of sufficient sample size is required. Potentially, EPO stabilizes the hemoglobin levels of these infants and thus prevents top-up transfusions and extra admissions, creating a more stable and natural postnatal course for patients with HDN.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||RCT with unblinded treatment allocation 1:1 ratio. Either treatment with darbepoetin alfa or "standard care". No placebo.|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial on the Use of EPO to Reduce Top-up Transfusions in Neonates With Red Blood Cell Alloimmunization Treated With Intrauterine Transfusions|
|Actual Study Start Date :||October 31, 2017|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Active Comparator: Darbepoetin alfa group
Group treated with darbepoetin alfa (Aranesp) 10microg/kg once a week for a period of 8 weeks.
Drug: Darbepoetin Alfa
Darbepoetin alfa dosage 10microg/kg once a week for 8 weeks
Other Name: Aranesp
No Intervention: Control group
"Standard care" which involves close monitoring of hemoglobin levels and if necessary, top-up red cell transfusion.
- Number of top-up transfusions required per infant [ Time Frame: First 3 months of life ]Number of top-up transfusions required per infant
- The percentage of infants requiring a top-up transfusion [ Time Frame: First 3 months of life ]The percentage of infants requiring a top-up transfusion
- Number of days of admission for top-up transfusions [ Time Frame: First 3 months of life ]Number of days of admission for top-up transfusions
- Occurrence of hypertension [ Time Frame: 8 weeks (treatment course) ]The percentage of infants with a systolic blood pressure ≥ 2 SD above age adjusted mean systolic blood pressure during treatment
- Occurrence of high ferritin levels [ Time Frame: 8 weeks (treatment course) ]The percentage of infants with ferritin levels >200 μg/L during treatment
- Long-term neurodevelopmental outcome [ Time Frame: 2 years of age ]Exploratory outcome; Long-term neurodevelopmental outcome at 2 years of age using the BSID-III test
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|Ages Eligible for Study:||up to 2 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- all (near)-term neonates (gestational age ≥ 35 weeks) admitted to the Leiden University Medical Center (LUMC) with HDFN, treated with IUT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104426
|Contact: Isabelle MC Ree, MDfirstname.lastname@example.org|
|Contact: Enrico Lopriore, MD PhDemail@example.com|
|Leiden University Medical Center||Recruiting|
|Leiden, Netherlands, 2300RC|
|Contact: Enrico Lopriore, MD Phd E.Lopriore@lumc.nl|
|Principal Investigator:||Masja de Haas, MD PhD||Sanquin Research|
Documents provided by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research:
|Responsible Party:||Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research|
|Other Study ID Numbers:||
|First Posted:||April 7, 2017 Key Record Dates|
|Last Update Posted:||October 2, 2019|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Hemolytic disease of the fetus and newborn
Red blood cell alloimmunization
Female Urogenital Diseases and Pregnancy Complications
Infant, Newborn, Diseases
Immune System Diseases