CD71 in Dried Blood Spots in Healthy Males

Healthy Athletes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073849
• Other study ID #: SMRTL-2018_02
• Status: Completed
• Phase: Early Phase 1
• Start date: July 15, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2019
• Source: Sports Medicine Research and Testing Laboratory
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Athletes

Intervention

Drug:
• EPOGEN® (epoetin alfa)
Active drug

Other:
• Normal Saline
Placebo

Locations

Country	Name	City	State
United States	Sports Medicine Research and Testing Laboratory	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Sports Medicine Research and Testing Laboratory

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 months
Primary	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	8 months
Primary	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	8 months
Primary	Calculated OFF-score	Calculated using the formula: OFF-score = Hgb - 60*vRet%, 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	8 months
Primary	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.	8 months
Secondary	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: Direct detection of the rEPO drug in urine, serum (and/or plasma), and dried blood spots; b. Athlete Biological Passport adaptive model	12 months
Secondary	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.	12 months