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Erythropoiesis-Stimulating Agent

Epoetin Alfa for Exercise-Induced Anemia

Phase 4
Waitlist Available
Research Sponsored by United States Army Research Institute of Environmental Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial is looking at whether or not EPO (a potential intervention) can help maintain physical performance in people who are doing strenuous physical activity.

Eligible Conditions
  • Exercise-Induced Anemia
  • Physical Fitness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentration of Hemoglobin
Time to complete 5 km time trial
Secondary outcome measures
Rate of Carbohydrate and Fat Oxidation

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Exogenous ErythropoietinExperimental Treatment1 Intervention
Recombinant human Erythropoietin subcutaneous injection of 50 IU/kg body mass 3 times per week for 4 week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erythropoietin
FDA approved

Find a Location

Who is running the clinical trial?

United States Army Research Institute of Environmental MedicineLead Sponsor
59 Previous Clinical Trials
3,422 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass those above the age of 25?

"The study has delineated a specific age range for participation, namely those aged 18 and under 39."

Answered by AI

What therapeutic applications is Epoetin Alfa generally employed for?

"Epoetin Alfa is the preferred treatment for those at risk of significant blood loss. This medication can also target other conditions, including HIV, surgery-related hemorrhaging and chemotherapy-induced myelosuppression."

Answered by AI

Who would make the best candidates for this clinical investigation?

"This medical trial requires 24 participants, aged between 18 and 39 years old who possess physical aptitude. Additionally, they should maintain their weight within 5 pounds of its baseline value for two months prior to the start date; be recreationally active at least 2-4 days per week doing either aerobic or resistance exercise; abstain from taking any nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin 10 days before muscle biopsy and at least five after; have a BMI ranging between 18.5 - 30 kg/m2; stay off alcohol and nicotine while on study diets."

Answered by AI

Has the FDA sanctioned Epoetin Alfa for use?

"According to our team's assessment, Epoetin Alfa has been granted a safety score of 3 given it is in its final phase (Phase 4) and already approved for use."

Answered by AI

Is this experiment seeking participants at the present time?

"Affirmative, clinicaltrials.gov's data attests that this research is currently searching for participants. The trial was published on September 1st 2021 and recently updated on October 13th 2021 with the goal of recruiting 24 individuals from a single site."

Answered by AI

How many volunteers have been recruited to participate in this medical experiment?

"Indeed, according to clinicaltrials.gov this medical trial is currently enrolling individuals for participation. Initially listed on September 1st 2021 and last updated on October 13th 2021, the study has a goal of engaging 24 subjects at one centre."

Answered by AI

Has there been any previous research conducted on Epoetin Alfa?

"Currently, 19 separate clinical trials are investigating the efficacy of Epoetin Alfa. 8 of these active studies have entered Phase 3 and there are a total of 1110 locations running research into this therapy; the majority being located in Palma de Mallorca, Islas Baleares."

Answered by AI
~2 spots leftby Apr 2025