HealthyPhase 1/2NCT01889056
Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans
A Phase 1/2 study testing Erythropoietin (Epoetin beta) in people with Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the brain, especially under hypoxic conditions. It has been shown in animal studies and human studies that Epo has neuroprotective properties. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Erythropoietin (Epoetin beta)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Dec 2013
- Phase
- Phase 1/2
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Subjects;
- Age between 18 to 35 years;
- Normal body weight (body mass index of >= 18.5 kg/m2 <= 24.9 kg/m2);
- Nonsmokers (>= 1 year);
- VO2max of <= 55 ml/kg/min for females and <= 60 ml/kg/min for males;
Who cannot join
- Persons with abnormal Serum Ferritin levels according to gender dependent reference values of GCP-certificated laboratory;
- Persons with pre-existing genetic hemostatic disorders (Factor V Leiden mutation, Prothrombin mutation);
- Persons which are at risk of deep venous thrombosis (e.g. history of venous thromboembolic events);
- Persons with a hematocrit value of > 55%;
- Persons being exposed to prolonged (>= 5 days) high altitude (>= 2500m above Normal Null) <= 6 months prior the beginning of the study;
- Persons not willing to maintain their living conditions during the study period (e.g. preparing for a certain competition);
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- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
- Pregnant or breast feeding women;
- Intention to become pregnant during the course of the study;
- Lack of safe contraception;
- Treatment with other investigational products;
- Known or suspected non-compliance, drug or alcohol abuse;
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders;
- Participation in another study with investigational drug within the 30 days preceding and during the present study;
- Enrolment of the investigator, his/her family members, employees and other dependent persons;
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Medical intensive care unit
Zurich, Canton of Zurich, 8091
About this study
The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the brain, especially under hypoxic conditions. It has been shown in animal studies and human studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome the blood brain barrier. In a double blind placebo controlled crossover study we will investigate the effects of a single high dose of Epo on cognitive function and exercise capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU) and will perform a computerized cognitive test battery, a breathing test, a maximal exercise capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary outcome of the study will be the cognitive function.
- Trial with medicinal product
- Conditions
- Healthy
- Being tested
- Erythropoietin (Epoetin beta), Placebo
- Keywords
- Erythropoietin, Cognition, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoietin (Epoetin beta)Drug
Also called Recormon
PlaceboDrug
0.9% sodium chloride solution
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin (Epoetin beta) | Experimental | Short infusion of 60.000 IU Epoetin beta in 0.9% sodium chloride solution (250 ml) Receives: Drug: Erythropoietin (Epoetin beta) |
| 0.9% sodium chloride solution | Placebo comparator | Short infusion of 0.9% sodium chloride solution (250 ml) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
The following parameters of cognitive function will be tested via computer-based cognitive testing (Units: Scores, Percent Correct, Response time):
- Working memory capacity
- Executive function
- Processing speed
Measured: 1 year
Secondary outcomes (1)
Exercise Capacity
Evaluation of exercise capacity via specific exercise tests:
- VO2max test
- 20-minutes time trial (TT)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (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.
- More trials run by University of ZurichThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Maggiorini, Prof MD, Principal investigator, University Hospital Zurich, Medical intensive care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889056
- Sponsor's protocol ID
- EPOPERF CH12
- Status last verified
- Jun 2013
- First submitted
- 26 Feb 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans
- ClinicalTrials.gov ID
- NCT01889056
- Acronym / sponsor ID
- EPOPERF CH12
- Conditions
- Healthy
- Keywords
- Erythropoietin, Cognition, Exercise
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 28 Jun 2013 (estimated)
- 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 blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the brain, especially under hypoxic conditions. It has been shown in animal studies and human studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome the blood brain barrier. In a double blind placebo controlled crossover study we will investigate the effects of a single high dose of Epo on cognitive function and exercise capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU) and will perform a computerized cognitive test battery, a breathing test, a maximal exercise capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary outcome of the study will be the cognitive function.
- Trial with medicinal product
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin (Epoetin beta) | Experimental | Drug: Erythropoietin (Epoetin beta)Short infusion of 60.000 IU Epoetin beta in 0.9% sodium chloride solution (250 ml) |
| 0.9% sodium chloride solution | Placebo comparator | Drug: PlaceboShort infusion of 0.9% sodium chloride solution (250 ml) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Subjects;
- Age between 18 to 35 years;
- Normal body weight (body mass index of >= 18.5 kg/m2 <= 24.9 kg/m2);
- Nonsmokers (>= 1 year);
- VO2max of <= 55 ml/kg/min for females and <= 60 ml/kg/min for males;
Key exclusion criteria (15 listed)
- Persons with abnormal Serum Ferritin levels according to gender dependent reference values of GCP-certificated laboratory;
- Persons with pre-existing genetic hemostatic disorders (Factor V Leiden mutation, Prothrombin mutation);
- Persons which are at risk of deep venous thrombosis (e.g. history of venous thromboembolic events);
- Persons with a hematocrit value of > 55%;
- Persons being exposed to prolonged (>= 5 days) high altitude (>= 2500m above Normal Null) <= 6 months prior the beginning of 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 |
|---|---|---|
| Erythropoietin (Epoetin beta)Also: Recormon | Drug | Erythropoietin (Epoetin beta) |
| Placebo0.9% sodium chloride solution | Drug | 0.9% sodium chloride solution |
Primary outcome
Cognitive Function
Time frame: 1 year
The following parameters of cognitive function will be tested via computer-based cognitive testing (Units: Scores, Percent Correct, Response time): * Working memory capacity * Executive function * Processing speed
1 secondary outcome
Exercise Capacity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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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.
Marco Maggiorini, Prof MD principal investigator
University Hospital Zurich, Medical intensive care unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Erythropoietin (Epoetin beta) in people with Healthy, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 15 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 28 Jun 2013. 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 Switzerland. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Cognitive Function (time frame: 1 year). 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 28 Jun 2013.