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Healthy AthletesEarly Phase 1NCT04073849

CD71 in Dried Blood Spots in Healthy Males

A Early Phase 1 study testing EPOGEN® (epoetin alfa) and Normal Saline in people with Healthy Athletes, run by Sports Medicine Research and Testing Laboratory at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Athletes
What is being tested?
EPOGEN® (epoetin alfa) and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
15 Jul 2019to 1 Dec 2020
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

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 locations and contacts

1 site in 1 country.

United States1 site

  • Sports Medicine Research and Testing Laboratory

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

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

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
Read the 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.

Being tested
EPOGEN® (epoetin alfa), Normal Saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPOGEN® (epoetin alfa)Drug

    Also called erythropoietin, rEPO

    Active drug

  • Normal SalineOther

    Also called Saline

    Placebo

Study groups in NCT04073849
Study groupRoleWhat they receive
Cohort AActive comparatorEPOGEN® (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
Receives: Drug: EPOGEN® (epoetin alfa)
Cohort BSham comparatorSaline 40 IU / kg dose during boosting phase, delivered s.c.; 8 injections 900 IU dose during microdosing, delivered i.v.; 6 injections
Receives: Other: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 months

  2. 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

    Measured: 8 months

  3. 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

    Measured: 8 months

  4. 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

    Measured: 8 months

  5. 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.

    Measured: 8 months

Secondary outcomes (2)

  1. 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:

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

    Measured: 12 months

  2. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2019
  2. Study start15 Jul 2019
  3. Primary completion15 Nov 2020
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cohort A to receive active drug Cohort B to receive placebo, (saline)
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04073849
Sponsor's protocol ID
SMRTL-2018_02
Status last verified
Mar 2019
First submitted
28 Jul 2019
Last updated
17 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing EPOGEN® (epoetin alfa) and Normal Saline in people with Healthy Athletes, run by Sports Medicine Research and Testing Laboratory at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD71 (transferrin receptor) concentration (time frame: 8 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04073849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.

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