HealthyNCT03700515
Exosome Proteomics to Detect EPO
A study testing Erythropoietin in people with Healthy, run by Morten Hostrup, PhD at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Sep 2019to 15 Oct 2020
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- VO2max of at least 55+/-2 for men and 50+/-2 for women
- BMI between 18 and 27
- Resting hematocrit of less than 46%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
August Krogh Building
Copenhagen
Morten Hostrup, PhD, +4524474785, mhostrup@nexs.ku.dk
About this study
Official title: Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes
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.
- Conditions
- Healthy
- Being tested
- Erythropoietin, Placebo
- Keywords
- EPO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Subjects receive weekly infusions of EPO
PlaceboDrug
Subjects receive weekly infusions of saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline infusion Receives: Drug: Placebo |
| EPO | Experimental | Erythropoetin infusion (9 IU/kg) Receives: Drug: Erythropoietin |
| EPO II | Experimental | Erythropoetin infusion (20 IU/kg) Receives: Drug: Erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood proteome enrichment pathway analysis in GO annotation
Change in enrichment (measured in blood and assessed using GO annotation)
Measured: At baseline and after week 3 of treatment
Secondary outcomes (1)
Blood markers of iron
Change in blood markers of iron homeostasis
Measured: At baseline and after week 3 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start4 Sep 2019
- Primary completion15 Oct 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morten Hostrup, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tasmania
- Responsible party
- Sponsor-investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700515
- Sponsor's protocol ID
- EPO-EXO
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes
- ClinicalTrials.gov ID
- NCT03700515
- Acronym / sponsor ID
- EPO-EXO
- Conditions
- Healthy
- Keywords
- EPO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Collaborators
- University of Tasmania
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSaline infusion |
| EPO | Experimental | Drug: ErythropoietinErythropoetin infusion (9 IU/kg) |
| EPO II | Experimental | Drug: ErythropoietinErythropoetin infusion (20 IU/kg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- VO2max of at least 55+/-2 for men and 50+/-2 for women
- BMI between 18 and 27
- Resting hematocrit of less than 46%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErythropoietinSubjects receive weekly infusions of EPO | Drug | EPO, EPO II |
| PlaceboSubjects receive weekly infusions of saline | Drug | Placebo |
Primary outcome
Blood proteome enrichment pathway analysis in GO annotation
Time frame: At baseline and after week 3 of treatment
Change in enrichment (measured in blood and assessed using GO annotation)
1 secondary outcome
Blood markers of iron
Time frame: At baseline and after week 3 of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythropoietin in people with Healthy, run by Morten Hostrup, PhD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. 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 Denmark. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood proteome enrichment pathway analysis in GO annotation (time frame: At baseline and after week 3 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2019.