CD71 in Dried Blood Spots in Healthy Males

Early Phase 1CompletedNCT04073849

Sports Medicine Research and Testing Laboratory24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Healthy Athletes

Interventions

EPOGEN® (epoetin alfa)DRUG

Active drug

Normal SalineOTHER

Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \- Participants should have ferritin \> 35 ng/mL and transferrin saturation \> 20% at the time of enrollment Exclusion Criteria: Individuals currently enrolled in a registered testing pool for anti-doping purposes * 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

Locations (1)

Sports Medicine Research and Testing Laboratory

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Data from ClinicalTrials.gov

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