Evaluation of CD71 Expression in a Dried Blood Spot Following rEPO Administration
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Reticulocyte percentage (Ret%)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Online randomization tool
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort A
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
干预措施: EPOGEN® (epoetin alfa) (Drug)
Cohort B
Saline 40 IU / kg dose during boosting phase, delivered s.c.; 8 injections 900 IU dose during microdosing, delivered i.v.; 6 injections
干预措施: Normal Saline (Other)
结局指标
主要结局
Reticulocyte percentage (Ret%)
时间窗: 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
Immature reticuocyte fraction
时间窗: 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.
CD71 (transferrin receptor) concentration
时间窗: 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.
Hemogloblin concentration
时间窗: 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
Calculated OFF-score
时间窗: 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
次要结局
- Window of detection (detectability time) following rEPO use(12 months)
- Analytical detection of rEPO in a dried blood spot(12 months)