Clinical trial NCT04073849: CD71 in Dried Blood Spots in Healthy Males
Official title: Evaluation of CD71 Expression in a Dried Blood Spot Following rEPO Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Athletes
Lead sponsor: Sports Medicine Research and Testing Laboratory
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort A to receive active drug Cohort B to receive placebo, (saline)
Primary purpose: OTHER

Brief summary: 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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: CD71 (transferrin receptor) concentration
timeFrame: 8 months
measure: Hemogloblin concentration
timeFrame: 8 months
measure: Reticulocyte percentage (Ret%)
timeFrame: 8 months
measure: Calculated OFF-score
timeFrame: 8 months
measure: Immature reticuocyte fraction
timeFrame: 8 months
Secondary outcomes:
measure: Window of detection (detectability time) following rEPO use
timeFrame: 12 months
measure: Analytical detection of rEPO in a dried blood spot
timeFrame: 12 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Sports Medicine Research and Testing Laboratory
state: Utah
Study officials:
affiliation: Sports Medicine Research and Testing Laboratory
name: Daniel Eichner, PhD
role: STUDY_DIRECTOR
affiliation: Sports Medicine Research and Testing Laboratory
name: Andre Crouch, MD
role: PRINCIPAL_INVESTIGATOR
References: