CClinicalTrials.gg
Status unknownNCT03700515Updated Sep 25, 2019

Exosome Proteomics to Detect EPO

An interventional study of Erythropoietin and Placebo in Healthy, sponsored by Morten Hostrup, PhD. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by Morten Hostrup, PhD · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The role of exosomes in cell signalling has only recently been appreciated and is a hugely exciting and rapidly growing area, and combined with LC-MS/MS proteomics, can overcome traditional barriers to proteomics in doping applications. To our knowledge, no research has yet been undertaken to explore whether the highly promising combination of exosome proteomics has utility for rhEPO detection. The applications are extensive; the diagnostic value of differentially regulated proteins could be further validated against the existing IEF EPO WADA accredited tests using samples collected during this study, used to study altitude hypoxia versus exogenous EPO administration (WADA current targeted research 2017), investigated as a platform approach to ESA and HIF agents more generally, as well as facilitate development of direct ELISA high throughput tests.

02

Conditions studied

  • Healthy

Keywords

  • EPO
03

In context

Lead sponsor

Morten Hostrup, PhD is the lead sponsor of 14 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • VO2max of at least 55+/-2 for men and 50+/-2 for women
  • BMI between 18 and 27
  • Resting hematocrit of less than 46%

Exclusion criteria

Exclusion Criteria:

  • Chronic disease deemed by the medical doctor to affect the outcome
  • Competitive athlete subject to doping control
  • Use of other prescription medicine deemed by the medical doctor to interact with the study drug
  • Allergy or otherwise unacceptable side effects toward the study drug
  • Smoker
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Saline infusion

    Drug: Placebo

  • Experimental
    EPO

    Erythropoetin infusion (9 IU/kg)

    Drug: Erythropoietin

  • Experimental
    EPO II

    Erythropoetin infusion (20 IU/kg)

    Drug: Erythropoietin

Interventions

  • DrugErythropoietin

    Subjects receive weekly infusions of EPO

  • DrugPlacebo

    Subjects receive weekly infusions of saline

06

What researchers measure

Primary outcomes

  1. Blood proteome enrichment pathway analysis in GO annotation

    Change in enrichment (measured in blood and assessed using GO annotation)

    Time frame: At baseline and after week 3 of treatment

Secondary outcomes

  1. Blood markers of iron

    Change in blood markers of iron homeostasis

    Time frame: At baseline and after week 3 of treatment

07

Study locations

1 of 1 sites recruiting
  • August Krogh Building
    Copenhagen, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03700515
Lead sponsor
Morten Hostrup, PhD
Collaborators
University of Tasmania
Responsible party
Morten Hostrup, PhD (Associate Professor, University of Copenhagen) — Sponsor-investigator
First posted
Oct 9, 2018
Start date
Sep 4, 2019
Primary completion
Oct 15, 2020 (estimated)
Completion
Oct 15, 2020 (estimated)
Last update
Sep 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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