CD71 in Dried Blood Spots in Healthy Males

Sports Medicine Research and Testing Laboratory (SMRTL)

Status and phase: Completed; Early Phase 1

Conditions: Healthy Athletes

Treatments: Drug: EPOGEN® (epoetin alfa); Other: Normal Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT04073849

SMRTL-2018_02

Details and patient eligibility

About

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

Full description

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Cohort A

Active Comparator group

Description:

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

Treatment:

Drug: EPOGEN® (epoetin alfa)

Cohort B

Sham Comparator group

Description:

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

Treatment:

Other: Normal Saline