Chronic Kidney FailurePhase 1NCT01085552
Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects
A Phase 1 study testing Epoetin Beta in people with Chronic Kidney Failure and Anaemia, run by InCROM Europe Clinical Research.
Trial summary
A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian Male subjects. Each subject received a single subcutaneous dose of 50IU/kg of NeoRecormon Multidose solution on Day 1. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Failure, Anaemia
- What is being tested?
- Epoetin Beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Oct 2008
- Phase
- Phase 1
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male Japanese volunteers (both parents and all four grandparents must be Japanese, and subject must have been born in Japan, subjects should usually reside in Japan but can have been resident outside of Japan for up to 5 years), or Healthy male Caucasian volunteers.
- Aged between 20 and 40 years of age.
- Body weight of 50kg - 80 kg inclusive with a Body mass index (BMI) between 18 - 29 kg/m2 inclusive at screening.
- Subjects must be in good health as determined by a medical history, medical examination, electrocardiogram, serum biochemistry, haematology, serology and urinalysis.
- Provide their written informed consent to participate in the trial after reading the information and consent form, and after having opportunity to discuss the trial with the investigator or delegate.
- Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and/or delegate and participate in, and comply with the requirement's of the entire trial.
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- Willing to abstain from Alcohol consumption from 48 hours before trial drug administration until last outpatient visit.
- Subjects must be willing to use one of the following methods of contraception from the first dose of trial medication until completion of follow-up procedures:In addition to the use of condom and spermicide (foam/gel/film), male subjects without a vasectomy must assure that their female partner uses another form of contraception such as an IUD, diaphragm or hormonal contraception if the female partner could become pregnant from the time of the first dose of trial medication until one month after the follow up visit.
- Have an upper limit of14g/dL for haemoglobin, 45% for Hematocrit and 1.9% for Reticulocytes.
- Have normal safety results for Creatinine, Liver function tests, serum Ferritin, Folic acid and vitamin B12 at the screening assessment
Who cannot join
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the screening visit that could interfere with the objective of the trial or the safety of the volunteer.
- Clinically significant illness within 4 weeks prior to the screening visit.
- Subjects with past or present histories of liver disease, angina, renal disease, hypertension, epilepsy, cardiovascular, cerebrovascular, thrombocytosis or peripheral vascular disease.
- Subjects who have used any systemic, topical prescription, non-prescription or herbal medication within 14 days of start of dosing with the exception of paracetamol up to 3g per day.
- Subjects who smoke more than 5 cigarettes per day.
- Subjects who have donated 400ml of blood during the 1 month before dosing.
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- Subjects who have received an investigational product 3 months preceding the trial.
- Subjects who have a clinically significant history of drug hypersensitivity or allergic disease.
- Subjects who consume more than 28 units of alcohol per week or who have history of alcoholism or evidence of drug/chemical abuse. (one unit of alcohol equals ½ pint [285 ml] of beer or lager, one glass [125 ml] of wine or l [25ml] of spirits)
- Subjects who consume excessive amounts of caffeine (more than 5 cups or equivalent per day.
- Subjects with a positive urine drug screen at the screening visit or admission.
- Subjects with known history or evidence of hepatitis B, hepatitis C or HIV1 or HIV2.
- Subjects who in the opinion of their GP or the investigator should not participate in the study.
- Possibility that the subject will not cooperate with the requirements of the protocol as set out in the volunteer information.
- Subjects with any previous exposure to erythropoietin
About this study
Official title: A Phase I Single Centre Open Label Trial to Investigate the Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta (NeoRecormon®) in Healthy Japanese and Caucasian Male Subjects
A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian Male subjects. Each subject received a single subcutaneous dose of 50IU/kg of NeoRecormon Multidose solution on Day 1.
Read the detailed description
Ethnic comparison studies are becoming common research requirements in order to identify differences in response to drugs in various ethnic populations. This study will investigate the pharmacokinetic parameters and pharmacodynamic response in healthy Caucasian and Japanese male subjects after a single subcutaneous administration of 50IU/kg Epoetin beta
This is a Phase I single centre, open label trial to investigate the bioequivalence of a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese and Caucasian Male subjects.
The primary objectives are 1) to establish the pharmacokinetic parameters of Epoetin beta in healthy Japanese and Caucasian males, and 2) to compare the pharmacokinetic parameters AUCinf and Cmax in healthy Japanese and Caucasian males. The secondary objective is to establish the pharmacodynamic parameters of a single dose of Epoetin beta in healthy Japanese and Caucasian males.
Subjects will receive a single subcutaneous administration of 50IU/kg on one occasion only. The planned study duration is approximately 1 month.
- Conditions
- Chronic Kidney Failure, Anaemia
- Being tested
- Epoetin Beta
- Keywords
- NeoRecormon®, Caucasian, Japanese, Bioequivalence, Ethnic
- Medical subject headings
- Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin BetaDrug
Epoetin Beta. A single subcutaneous dose of 50IU/kg on Day 1. The body weight recording on day -1 will be used to calculate the dosage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Group A consists of 11 Caucasian male subjects Group B consists of 12 Japanese male subjects Receives: Drug: Epoetin Beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the pharmacokinetic parameters of Epoetin beta in healthy Japanese and Caucasian males.
Measured: 21 Oct 2008
To compare the pharmacokinetic parameters AUCinf and Cmax in healthy Japanese and Caucasian males.
Measured: 21 Oct 2008
Secondary outcomes (1)
To establish the pharmacodynamic parameters of a single dose of Epoetin beta in healthy Japanese and Caucasian males.
Measured: 21 Oct 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies 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 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- InCROM Europe Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daryl Bendel, MBChB MBA, Principal investigator, InCROM Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085552
- Sponsor's protocol ID
- EICE07060
- Status last verified
- Mar 2010
- First submitted
- 11 Mar 2010
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Centre Open Label Trial to Investigate the Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta (NeoRecormon®) in Healthy Japanese and Caucasian Male Subjects
- ClinicalTrials.gov ID
- NCT01085552
- Acronym / sponsor ID
- EICE07060
- Conditions
- Chronic Kidney Failure, Anaemia
- Keywords
- NeoRecormon®, Caucasian, Japanese, Bioequivalence, Ethnic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- InCROM Europe Clinical ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Mar 2010 (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.
A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian Male subjects. Each subject received a single subcutaneous dose of 50IU/kg of NeoRecormon Multidose solution on Day 1.
Detailed description
Ethnic comparison studies are becoming common research requirements in order to identify differences in response to drugs in various ethnic populations. This study will investigate the pharmacokinetic parameters and pharmacodynamic response in healthy Caucasian and Japanese male subjects after a single subcutaneous administration of 50IU/kg Epoetin beta
This is a Phase I single centre, open label trial to investigate the bioequivalence of a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese and Caucasian Male subjects.
The primary objectives are 1) to establish the pharmacokinetic parameters of Epoetin beta in healthy Japanese and Caucasian males, and 2) to compare the pharmacokinetic parameters AUCinf and Cmax in healthy Japanese and Caucasian males. The secondary objective is to establish the pharmacodynamic parameters of a single dose of Epoetin beta in healthy Japanese and Caucasian males.
Subjects will receive a single subcutaneous administration of 50IU/kg on one occasion only. The planned study duration is approximately 1 month.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Epoetin BetaGroup A consists of 11 Caucasian male subjects Group B consists of 12 Japanese male subjects |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male Japanese volunteers (both parents and all four grandparents must be Japanese, and subject must have been born in Japan, subjects should usually reside in Japan but can have been resident outside of Japan for up to 5 years), or Healthy male Caucasian volunteers.
- Aged between 20 and 40 years of age.
- Body weight of 50kg - 80 kg inclusive with a Body mass index (BMI) between 18 - 29 kg/m2 inclusive at screening.
- Subjects must be in good health as determined by a medical history, medical examination, electrocardiogram, serum biochemistry, haematology, serology and urinalysis.
- Provide their written informed consent to participate in the trial after reading the information and consent form, and after having opportunity to discuss the trial with the investigator or delegate.
Key exclusion criteria (15 listed)
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the screening visit that could interfere with the objective of the trial or the safety of the volunteer.
- Clinically significant illness within 4 weeks prior to the screening visit.
- Subjects with past or present histories of liver disease, angina, renal disease, hypertension, epilepsy, cardiovascular, cerebrovascular, thrombocytosis or peripheral vascular disease.
- Subjects who have used any systemic, topical prescription, non-prescription or herbal medication within 14 days of start of dosing with the exception of paracetamol up to 3g per day.
- Subjects who smoke more than 5 cigarettes per day.
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 |
|---|---|---|
| Epoetin BetaEpoetin Beta. A single subcutaneous dose of 50IU/kg on Day 1. The body weight recording on day -1 will be used to calculate the dosage | Drug | 1 |
Primary outcome
To establish the pharmacokinetic parameters of Epoetin beta in healthy Japanese and Caucasian males.
Time frame: 21 Oct 2008
To compare the pharmacokinetic parameters AUCinf and Cmax in healthy Japanese and Caucasian males.
Time frame: 21 Oct 2008
1 secondary outcome
To establish the pharmacodynamic parameters of a single dose of Epoetin beta in healthy Japanese and Caucasian males.
Time frame: 21 Oct 2008
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 12 Mar 2010.
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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.
Daryl Bendel, MBChB MBA principal investigator
InCROM Clinical Research Unit
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epoetin Beta in people with Chronic Kidney Failure and Anaemia, run by InCROM Europe Clinical Research.
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 10 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: finished, as of the sponsor's last update on 12 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To establish the pharmacokinetic parameters of Epoetin beta in healthy Japanese and Caucasian males. (time frame: 21 Oct 2008). The study lists 2 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 12 Mar 2010; AzTrials last refreshed its copy on 8 Nov 2026.