An Early Phase 1 interventional study of EPOGEN® (epoetin alfa) and Normal Saline in Healthy Athletes, sponsored by Sports Medicine Research and Testing Laboratory. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Sports Medicine Research and Testing Laboratory · Early Phase 1, Interventional, and Other
Understand the effect of recombinant EPO (rEPO) boosting and microdosing on the hematological module of the Athlete Biological Passport (ABP)
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.
Sports Medicine Research and Testing Laboratory is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Inclusion Criteria: Active individuals, preferably those that participate regularly in endurance athletics either for sport or for leisure, between the ages of 18 and 45
Exclusion Criteria: Individuals currently enrolled in a registered testing pool for anti-doping purposes
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
Drug: EPOGEN® (epoetin alfa)
Saline 40 IU / kg dose during boosting phase, delivered s.c.; 8 injections 900 IU dose during microdosing, delivered i.v.; 6 injections
Other: Normal Saline
Active drug
Also known as: erythropoietin, rEPO
Placebo
Also known as: Saline
CD71 (transferrin receptor) concentration
CD71 concentration will be measured during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO. These data, especially when comparing to the variability in CD71 in the placebo cohort, may be extrapolated in the anti-doping framework to detect rEPO abuse by athletes.
Time frame: 8 months
Hemogloblin concentration
Hemoglobin concentration will be measured during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO
Time frame: 8 months
Reticulocyte percentage (Ret%)
Ret% will be measured during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO
Time frame: 8 months
Calculated OFF-score
Calculated using the formula: OFF-score = Hgb - 60\*√Ret%, OFF-score will be calculated from each collection during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO
Time frame: 8 months
Immature reticuocyte fraction
The immature reticulocyte fraction (IRF) will be measured during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO.
Time frame: 8 months
Window of detection (detectability time) following rEPO use
The length of time (following both the subcutaneous 'boosting' phase and the intravenous 'microdosing' phase) that rEPO use is evident will be assessed. This will be assessed using different criteria: 1. Direct detection of the rEPO drug in urine, serum (and/or plasma), and dried blood spots 2. b. Athlete Biological Passport adaptive model
Time frame: 12 months
Analytical detection of rEPO in a dried blood spot
Dried blood spot samples will be extracted and analyzed using analytical techniques (namely SAR-PAGE, SDS-PAGE, IEF-PAGE, or others) employed by the laboratory for the direct detection of rEPO.
Time frame: 12 months
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Sports Medicine Research and Testing Laboratory