CD71 in Dried Blood Spots in Healthy Males

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2020-12-01

Brief Summary

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Understand the effect of recombinant EPO (rEPO) boosting and microdosing on the hematological module of the Athlete Biological Passport (ABP)

* Measure the change in CD71 longitudinally in subjects from both cohorts
* Assess whether rEPO administration can be detected in a dried blood spot (DBS) using recent advances in analytical methodologies
* Compare windows of rEPO detection using both Athlete Biological Passport models and direct detection using analytical methods in urine, blood, and DBS

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Detailed Description

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Despite being banned by the World Anti-Doping Agency, blood doping is a common method of performance enhancement used by athletes wishing to gain an unfair advantage over their competition. A common way to achieve this increase is by using erythropoiesis stimulating agents (ESA's), namely recombinant erythropoietin (rEPO). Though laboratory tests have been developed for the direct detection of all known isoforms of exogenously administered ESAs in both urine and blood, athletes have found ways to circumvent these testing measures using techniques such as microdosing.

Conditions

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Healthy Athletes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cohort A to receive active drug Cohort B to receive placebo, (saline)

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Online randomization tool

Study Groups

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Cohort A

EPOGEN® (epoetin alfa) Study Drug Epoetin Alfa (EPOGEN®) 40 IU / kg dose during boosting phase, delivered s.c.; 8 injections 900 IU dose during microdosing, delivered i.v.; 6 injections

Group Type ACTIVE_COMPARATOR

EPOGEN® (epoetin alfa)

Intervention Type DRUG

Active drug

Cohort B

Saline 40 IU / kg dose during boosting phase, delivered s.c.; 8 injections 900 IU dose during microdosing, delivered i.v.; 6 injections

Group Type SHAM_COMPARATOR

Normal Saline

Intervention Type OTHER

Placebo

Interventions

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EPOGEN® (epoetin alfa)

Active drug

Intervention Type DRUG

Normal Saline

Placebo

Intervention Type OTHER

Other Intervention Names

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erythropoietin, rEPO Saline

Eligibility Criteria

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Inclusion Criteria

\- Participants should have ferritin \> 35 ng/mL and transferrin saturation \> 20% at the time of enrollment

Exclusion Criteria

* Individuals with the intent to compete in sanctioned athletic events during the study period
* Unwillingness to provide urine samples or blood samples
* Not actively exercising
* Individuals who show a high risk for MI/CAD, stroke, CHF, and venous thromboembolism (VTE)., as defined by the Principal Investigator
* Individuals with known drug allergies
* Individuals with EKG abnormalities, as determined by the Principal Investigator
* Individuals who have chronic kidney disease, HIV, cancer, hepatitis B, hepatitis C, or are planning surgery during the study
* Individuals with history of acute or chronic medical or psychiatric condition
* GFR (Creatinine clearance) \<60 mL/min
* Ferritin \>270 ng/mL
* Individuals who have a baseline hemoglobin concentration greater than 15.5 g/dL or a baseline hematocrit above 47%
* Individuals with blood or iron disorders, including polycythemia, hemochromatosis, anemia, or iron-deficiency anemia
* Individuals with a history of bleeding or bone marrow aplasia
* Individuals who are diabetic or with a history of cardiac or hepatic disease or history of drug abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes