ErythrocytosisNCT05833477
Tracing Changed Production of Red Blood Cells
A study testing Recombinant human erythropoietin in people with Erythrocytosis and Erythropoiesis Abnormal, run by University of Copenhagen at 1 site in Denmark.
Trial summary
In competitive sport, it is illegal to manipulate erythropoiesis. Manipulated erythropoiesis can indirectly be identified by atypical fluctuations in key haematological variables. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erythrocytosis, Erythropoiesis Abnormal
- What is being tested?
- Recombinant human erythropoietin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Oct 2022to 16 Dec 2022
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- 18-40 years
- physical fitness rating more than 50ml/kg/min
- non-smokers
- blood pressure <130/90 mmHg
- hemoglobin concentration 7-10.5 mM.
Who cannot join
- Blood donor who has donated blood within the last three months
- Participation in other concurrent clinical trials
- To participate in competitive sport during or three months after the study.
Trial locations and contacts
1 site in 1 country.
About this study
In competitive sport, it is illegal to manipulate erythropoiesis. Manipulated erythropoiesis can indirectly be identified by atypical fluctuations in key haematological variables. However, this method also has limitations and as it is known that some athletes still manipulate erythropoiesis it is necessary to develop new and more sensitive detection methods.
The primary purpose of the study is to examine the importance of altered erythropoiesis for surface and intracellular erythrocyte proteins, the number of immature reticulocytes, and for the haematological characteristics of the erythrocyte, such as volume, haemoglobin concentration and concentration of glycosylated haemoglobin, to assess whether these can be used to identify changed erythropoiesis. Furthermore, the aim is to examine whether these parameters are affected by freezer storage of erythrocytes.
- Conditions
- Erythrocytosis, Erythropoiesis Abnormal
- Being tested
- Recombinant human erythropoietin
- Medical subject headings
- Polycythemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human erythropoietinDrug
Recombinant human erythropoietin treatment three times per week for three weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Recombinant human erythropoietin treatment three times per week for three weeks Receives: Drug: Recombinant human erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CD71 expression
Treatment induced changes in CD71 expression on red blood cells
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in CD35 expression
Treatment induced changes in CD35 expression on red blood cells
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in CD47 expression
Treatment induced changes in CD47 expression on red blood cells
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in CD55 expression
Treatment induced changes in CD55 expression on red blood cells
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in CD59 expression
Treatment induced changes in CD59 expression on red blood cells
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in RNA expression
Treatment induced changes in RNA expression in red blood cells
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in Mean Cell Volume
Treatment induced changes in Mean Cell Volume distribution of red blood cells
Measured: In the period from two weeks before treatment to three weeks after treatment
Secondary outcomes (21)
Changes in HbA1c
Treatment induced changes in HbA1c content of red blood cells
Measured: In the period from two weeks before treatment to three weeks after treatment
Continous blood glucose levels
Continuous blood glucose level throughout the study
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in CD71 cryopreserved
CD71 expression on red blood cells before and after cryopreservation
Measured: Cryopreserved cells are measured 6 months after sample collection
Changes in CD35 cryopreserved
CD35 expression on red blood cells before and after cryopreservation
Measured: Cryopreserved cells are measured 6 months after sample collection
Changes in CD47 cryopreserved
CD47 expression on red blood cells before and after cryopreservation
Measured: Cryopreserved cells are measured 6 months after sample collection
Changes in CD55 cryopreserved
CD55 expression on red blood cells before and after cryopreservation
Measured: Cryopreserved cells are measured 6 months after sample collection
Changes in CD59 cryopreserved
CD59 expression on red blood cells before and after cryopreservation
Measured: Cryopreserved cells are measured 6 months after sample collection
Changes in RNA cryopreserved
RNA expression inred blood cells before and after cryopreservation
Measured: Cryopreserved cells are measured 6 months after sample collection
Changes in Mean Cell Volume cryopreserved
Mean Cell Volume distribution of red blood cells before and after cryopreservation
Measured: Cryopreserved cells are measured 6 months after sample collection
Changes in Ferritin
Quantification of plasma ferritin concentration
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in Complete Blood Count on Advia
Complete Blood Count analysis on the Advia 2120i instrument
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in Complete Blood Count on Sysmex
Complete Blood Count analysis on the Sysmex XN-450 instrument
Measured: In the period from two weeks before treatment to three weeks after treatment
Changes in Complete Blood Count on Advia - cryopreserved
Complete Blood Count analysis on the Advia 2120i instrument before and after cryopreservation
Measured: Cryopreserved cells are measured 6 months after sample collection
Changes in Complete Blood Count on Sysmex - cryopreserved
Complete Blood Count analysis on the Sysmex XN-450 instrument before and after cryopreservation
Measured: Cryopreserved cells are measured 6 months after sample collection
Changes in ALAS 2
Quantification of ALAS 2 in dried blood spots stored at room temperature, -20C and -80C
Measured: Up to 5 years
Changes in CA1
Quantification of CA1 in dried blood spots
Measured: Up to 5 years
Changes in SLC4a1
Quantification of SLC4a1 in dried blood spots
Measured: Up to 5 years
Changes in CD71 in dried blood spots
Quantification of CD71 in dried blood spots
Measured: Up to 5 years
Changes in FECH
Quantification of FECH in dried blood spots
Measured: Up to 5 years
Changes in Band 3
Quantification of Band 3 in dried blood spots
Measured: Up to 5 years
Changes in blood volume
Measurement of blood volume by CO rebreathing
Measured: Within 14 days before treatment and within 14 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start28 Oct 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythrocytosisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Bejder, Ph.D., Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833477
- Sponsor's protocol ID
- H-20064997
- Status last verified
- Apr 2023
- First submitted
- 22 Sep 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracing Changed Production of Red Blood Cells
- ClinicalTrials.gov ID
- NCT05833477
- Acronym / sponsor ID
- H-20064997
- Conditions
- Erythrocytosis, Erythropoiesis Abnormal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 27 Apr 2023 (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.
In competitive sport, it is illegal to manipulate erythropoiesis. Manipulated erythropoiesis can indirectly be identified by atypical fluctuations in key haematological variables. However, this method also has limitations and as it is known that some athletes still manipulate erythropoiesis it is necessary to develop new and more sensitive detection methods.
The primary purpose of the study is to examine the importance of altered erythropoiesis for surface and intracellular erythrocyte proteins, the number of immature reticulocytes, and for the haematological characteristics of the erythrocyte, such as volume, haemoglobin concentration and concentration of glycosylated haemoglobin, to assess whether these can be used to identify changed erythropoiesis. Furthermore, the aim is to examine whether these parameters are affected by freezer storage of erythrocytes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Recombinant human erythropoietinRecombinant human erythropoietin treatment three times per week for three weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy men
- 18-40 years
- physical fitness rating more than 50ml/kg/min
- non-smokers
- blood pressure <130/90 mmHg
Key exclusion criteria (3 listed)
- Blood donor who has donated blood within the last three months
- Participation in other concurrent clinical trials
- To participate in competitive sport during or three months after the study.
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 |
|---|---|---|
| Recombinant human erythropoietinRecombinant human erythropoietin treatment three times per week for three weeks | Drug | Treatment group |
Primary outcome
Changes in CD71 expression
Time frame: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD71 expression on red blood cells
Changes in CD35 expression
Time frame: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD35 expression on red blood cells
Changes in CD47 expression
Time frame: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD47 expression on red blood cells
Changes in CD55 expression
Time frame: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD55 expression on red blood cells
Changes in CD59 expression
Time frame: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD59 expression on red blood cells
Changes in RNA expression
Time frame: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in RNA expression in red blood cells
Changes in Mean Cell Volume
Time frame: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in Mean Cell Volume distribution of red blood cells
21 secondary outcomes
Changes in HbA1c
Time frame: In the period from two weeks before treatment to three weeks after treatment
Continous blood glucose levels
Time frame: In the period from two weeks before treatment to three weeks after treatment
Changes in CD71 cryopreserved
Time frame: Cryopreserved cells are measured 6 months after sample collection
Changes in CD35 cryopreserved
Time frame: Cryopreserved cells are measured 6 months after sample collection
Changes in CD47 cryopreserved
Time frame: Cryopreserved cells are measured 6 months after sample collection
Changes in CD55 cryopreserved
Time frame: Cryopreserved cells are measured 6 months after sample collection
Changes in CD59 cryopreserved
Time frame: Cryopreserved cells are measured 6 months after sample collection
Changes in RNA cryopreserved
Time frame: Cryopreserved cells are measured 6 months after sample collection
Changes in Mean Cell Volume cryopreserved
Time frame: Cryopreserved cells are measured 6 months after sample collection
Changes in Ferritin
Time frame: In the period from two weeks before treatment to three weeks after treatment
Changes in Complete Blood Count on Advia
Time frame: In the period from two weeks before treatment to three weeks after treatment
Changes in Complete Blood Count on Sysmex
Time frame: In the period from two weeks before treatment to three weeks after treatment
Changes in Complete Blood Count on Advia - cryopreserved
Time frame: Cryopreserved cells are measured 6 months after sample collection
Changes in Complete Blood Count on Sysmex - cryopreserved
Time frame: Cryopreserved cells are measured 6 months after sample collection
Changes in ALAS 2
Time frame: Up to 5 years
Changes in CA1
Time frame: Up to 5 years
Changes in SLC4a1
Time frame: Up to 5 years
Changes in CD71 in dried blood spots
Time frame: Up to 5 years
Changes in FECH
Time frame: Up to 5 years
Changes in Band 3
Time frame: Up to 5 years
Changes in blood volume
Time frame: Within 14 days before treatment and within 14 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Jacob Bejder, Ph.D. principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant human erythropoietin in people with Erythrocytosis and Erythropoiesis Abnormal, run by University of Copenhagen 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 27 Apr 2023. 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. 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?
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?
Changes in CD71 expression (time frame: In the period from two weeks before treatment to three weeks after treatment). The study lists 7 primary outcomes in all. 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 27 Apr 2023.