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Erythropoiesis-Stimulating Agent

Darbepoetin Alpha for Hypoxic-Ischemic Encephalopathy (MEND Trial)

Phase 2
Waitlist Available
Led By Tara L DuPont, MD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 - 12 months of age
Awards & highlights

MEND Trial Summary

This trial is testing whether a drug called Darbepoetin is safe and improves neurodevelopment in infants with perinatal acidemia and mild neonatal encephalopathy.

Eligible Conditions
  • Hypoxic-Ischemic Encephalopathy
  • Neonatal Encephalopathy

MEND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 - 12 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 - 12 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Normal Neurodevelopment
Secondary outcome measures
Percent of Infants With Adverse Events
Percent of Infants With Seizures
Percentage of Infants Who Need Gavage Feeds or Gastrostomy at Discharge Home
Other outcome measures
Percent With Failure to Thrive
Percent With Hearing Impairment
Percent With Seizures
+1 more

Side effects data

From 2017 Phase 4 trial • 2825 Patients • NCT00773513
31%
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

MEND Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Darbepoetin AlphaExperimental Treatment1 Intervention
IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at <24 hours of age
Group II: PlaceboPlacebo Group1 Intervention
IV, Normal saline (placebo dose), one dose at <24 hours of age
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darbepoetin Alfa
2008
Completed Phase 4
~5950

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,761 Total Patients Enrolled
University of UtahOTHER
1,099 Previous Clinical Trials
1,778,661 Total Patients Enrolled
Tara L DuPont, MDPrincipal InvestigatorUniversity of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mild Encephalopathy in the Newborn Treated With Darbepoetin
2017. "Mild Encephalopathy in the Newborn Treated With Darbepoetin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03071861.
~4 spots leftby Apr 2025
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