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Erythropoiesis-Stimulating Agent
Darbe + IV Iron for Premature Infants (DIVI Trial)
Phase 2
Recruiting
Led By Sandra E Juul, MD, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
NICU patients (male and female) born at 24-0/7 to 31-6/7 weeks of gestation
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 2 years corrected age.
Awards & highlights
DIVI Trial Summary
This trial is looking at whether giving preterm infants two types of iron, through IV, could potentially decrease transfusions, maintain iron levels, and improve neurodevelopment. The hypothesis is that this will be better tolerated than oral iron supplementation, with less effect on the gastrointestinal microbiome.
Who is the study for?
This trial is for preterm infants born between 24 and almost 32 weeks of gestation. It's open to all eligible NICU patients regardless of sex, race, or ethnicity. Infants with high iron levels, infections at enrollment, significant clinical anomalies, or whose parents cannot consent within 72 hours after birth are excluded.Check my eligibility
What is being tested?
The study tests if Darbepoetin (Darbe) combined with IV iron (Ferumoxytol or low molecular weight iron dextran) can reduce the need for blood transfusions while maintaining sufficient iron levels and improving neurodevelopment in premature infants compared to oral iron supplements.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, gastrointestinal disturbances due to oral supplements versus IV treatment differences in tolerance, and possible alterations in gut microbiome.
DIVI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born between 24 and 31 weeks of pregnancy.
DIVI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 and 2 years corrected age.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 2 years corrected age.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Blood transfusions
Number of IV iron doses required to maintain a ferritin level of > 75 ng/mL
Plasma Ferritin at 35-36 weeks PMA
+1 moreSecondary outcome measures
Early gut microbiome comparison between study groups
Hematocrit
Late gut microbiome comparison between study groups
+6 moreSide effects data
From 2017 Phase 4 trial • 2825 Patients • NCT0077351331%
Hypertension
19%
Diarrhoea
16%
Procedural hypotension
15%
Muscle spasms
14%
Bronchitis
14%
Urinary tract infection
14%
Cough
12%
Pneumonia
12%
Nasopharyngitis
12%
Constipation
12%
Arteriovenous fistula site complication
11%
Back pain
11%
Hyperparathyroidism secondary
11%
Upper respiratory tract infection
10%
Vomiting
10%
Anaemia
10%
Hypotension
10%
Hyperkalaemia
10%
Hyperphosphataemia
9%
Headache
9%
Fluid overload
9%
Atrial fibrillation
9%
Pain in extremity
8%
Arthralgia
8%
Pruritus
8%
Insomnia
8%
Arteriovenous fistula thrombosis
8%
Dyspnoea
7%
Osteoarthritis
7%
Gastroenteritis
7%
Nausea
7%
Pyrexia
6%
Dyspepsia
6%
Dizziness
6%
Abdominal pain
6%
Sepsis
6%
Influenza
6%
Musculoskeletal pain
6%
Oedema due to renal disease
5%
Oedema peripheral
5%
Acute myocardial infarction
5%
Cataract
5%
Depression
5%
Abdominal pain upper
5%
Respiratory tract infection
5%
Epistaxis
4%
Asthenia
4%
Myocardial infarction
4%
Lower respiratory tract infection
3%
Peritonitis
3%
Septic shock
3%
Cardiac arrest
3%
Angina pectoris
2%
Sudden death
2%
Device related sepsis
2%
Cardiac failure
2%
Acute coronary syndrome
2%
Cardiac failure congestive
2%
Syncope
2%
Cellulitis
2%
Gastrointestinal haemorrhage
2%
Device related infection
2%
Coronary artery disease
2%
Femur fracture
2%
Peripheral ischaemia
2%
Peripheral arterial occlusive disease
2%
Ischaemic stroke
2%
Cerebrovascular accident
2%
Death
2%
Pleural effusion
2%
Non-cardiogenic pulmonary oedema
2%
End stage renal disease
1%
Cholecystitis
1%
Non-cardiac chest pain
1%
Gangrene
1%
Staphylococcal bacteraemia
1%
Atrial flutter
1%
Subdural haematoma
1%
Femoral neck fracture
1%
Gastric ulcer haemorrhage
1%
General physical health deterioration
1%
Intestinal obstruction
1%
Hypertensive crisis
1%
Deep vein thrombosis
1%
Staphylococcal sepsis
1%
Bacteraemia
1%
Catheter site infection
1%
Cardiogenic shock
1%
Arteriovenous fistula aneurysm
1%
Arteriovenous fistula site infection
1%
Myocardial ischaemia
1%
Arteriovenous graft thrombosis
1%
Angina unstable
1%
Cardio-respiratory arrest
1%
Intestinal ischaemia
1%
Seizure
1%
Pancreatitis acute
1%
Colitis
1%
Cholecystitis acute
1%
Chest pain
1%
Arthritis bacterial
1%
Lung infection
1%
Hip fracture
1%
Pelvic fracture
1%
Peripheral artery stenosis
1%
Confusional state
1%
Infected skin ulcer
1%
Diverticulitis
1%
Erysipelas
1%
Endocarditis
1%
Peripheral vascular disorder
1%
Aortic stenosis
1%
Post procedural haemorrhage
1%
Rib fracture
1%
Head injury
1%
Large intestine polyp
1%
Rectal haemorrhage
1%
Gastritis
1%
Hypoglycaemia
1%
Cachexia
1%
Hyperglycaemia
1%
Diabetic foot infection
1%
Postoperative wound infection
1%
Bradycardia
1%
Aortic valve stenosis
1%
Arteriovenous fistula site haemorrhage
1%
Fall
1%
Extremity necrosis
1%
Transient ischaemic attack
1%
Pulmonary oedema
1%
Acute pulmonary oedema
1%
Chronic obstructive pulmonary disease
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Renal impairment
1%
Skin ulcer
1%
Diabetic foot
1%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erythropoiesis Stimulating Agents
Methoxy Polyethylene Glycol-Epoetin Beta
DIVI Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Group 5Experimental Treatment2 Interventions
Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 20 mg/kg x 1, retreat if ferritin < 76 mcg/L
Group II: Group 4Experimental Treatment2 Interventions
Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive FMX: 10 mg/kg x 1, retreat if ferritin < 76 mcg/L
Group III: Group 3Experimental Treatment2 Interventions
Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 20 mg/kg x 1, retreat if ferritin < 76 mcg/L
Group IV: Group 2Experimental Treatment2 Interventions
Infants randomized to this arm will receive Darbe 10 mcg/kg q week started on day 3 of life. In addition, beginning on day 7, they will receive LMW-ID: 10 mg/kg x 1, retreat if ferritin < 76 mcg/L
Group V: Group 1. Oral ironActive Control1 Intervention
Oral iron is started on day 7 of life if baby is feeding 100 mL/kg/day. Iron supplements of up to 12 mg/kg/day are given based on CBC, retic, ret-hgb, serum ferritin and zinc protoporphyrin to heme ratio (ZnPP/H). Iron supplements are adjusted every 2 weeks following iron studies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darbepoetin alfa
FDA approved
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,818 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,610 Total Patients Enrolled
Sandra E Juul, MD, PhDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
941 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand that eligibility is not based on my sex, race, ethnicity, background, or religion.Your blood thickness is higher than normal.Your blood tests show that you have a lot of iron in your body.My baby has been diagnosed with a significant health condition.My baby was born between 24 and 31 weeks of pregnancy.I cannot give consent in English or Spanish.I currently have a confirmed infection like sepsis or UTI.I am a mother and under 18 years old.My baby's parental consent was not obtained within 72 hours after birth.
Research Study Groups:
This trial has the following groups:- Group 1: Group 5
- Group 2: Group 1. Oral iron
- Group 3: Group 2
- Group 4: Group 3
- Group 5: Group 4
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What efficacy does Darbepoetin Alfa possess as a remedy?
"There is some evidence suggesting the safety of Darbepoetin Alfa, thus it has been rated a 2 on our team's scale. As this trial is in Phase 2, there are no results yet supporting its efficacy."
Answered by AI
How many participants are being recruited for this trial?
"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, which was introduced to the public on October 10th 2022, is actively seeking enrollees. Approximately 120 patients need to be recruited from a single location."
Answered by AI
Is this research endeavor presently open to participants?
"Clinicaltrials.gov reveals that this clinical trial is presently recruiting participants, having first been made available on October 10th 2022 and recently updated on the 13th of the same month."
Answered by AI
What is the ultimate objective of this trial?
"Throughout the 36 week postmenstrual (or pre-discharge) period, this clinical trial aims to compare anaphylaxis rates between treatment groups. Secondary objectives include contrasting transfusion free status and microbial diversity of stool samples before and after first iron dose, as well as assessing any discrepancies in Brainstem auditory evoked response latency across study arms."
Answered by AI
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