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OpenTrials
Completed

NCT Number: NCT04073849

CD71 in Dried Blood Spots in Healthy Males

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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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Sports Medicine Research and Testing Laboratory

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPOGEN® (epoetin alfa)

Drug

Active drug

Other names: erythropoietin, rEPO

Normal Saline

Other

Placebo

Other names: Saline

Primary outcomes

  1. CD71 (transferrin receptor) concentration

    Time frame: 8 months

    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.

  2. Hemogloblin concentration

    Time frame: 8 months

    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

  3. Reticulocyte percentage (Ret%)

    Time frame: 8 months

    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

  4. Calculated OFF-score

    Time frame: 8 months

    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

  5. Immature reticuocyte fraction

    Time frame: 8 months

    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.

Secondary outcomes

  1. Window of detection (detectability time) following rEPO use

    Time frame: 12 months

    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:

    • Direct detection of the rEPO drug in urine, serum (and/or plasma), and dried blood spots
    • b. Athlete Biological Passport adaptive model
  2. Analytical detection of rEPO in a dried blood spot

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Sports Medicine Research and Testing Laboratory

Industry

Registry information

Official study title

Evaluation of CD71 Expression in a Dried Blood Spot Following rEPO Administration

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2019
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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