AnemiaPhase 4NCT00413101
A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.
A Phase 4 study testing epoetin beta [NeoRecormon] in people with Anemia, run by Hoffmann-La Roche at 1 site in Serbia.
Trial summary
This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia
- What is being tested?
- epoetin beta [NeoRecormon]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSerbia
- Study dates
- Start not givento Mar 2008
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-75 years of age;
- end-stage renal disease;
- on renal dialysis >= 3 months;
- receiving NeoRecormon treatment >= 3 months;
- Hb stable and <105g/L, and LVMI >160g/m2.
Who cannot join
- unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
- use of any ESA other than NeoRecormon;
- acute infection;
- use of iv NeoRecormon.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon
This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
- Conditions
- Anemia
- Being tested
- epoetin beta [NeoRecormon]
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin beta [NeoRecormon]Drug
At a dose to achieve and maintain an Hb level of 120-135g/L
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: epoetin beta [NeoRecormon] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb level, BP.
Measured: Throughout study
LVMI ejection fraction, ejection fraction.
Measured: 12 months
Secondary outcomes (1)
SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413101
- Sponsor's protocol ID
- ML20201
- Status last verified
- May 2009
- First submitted
- 18 Dec 2006
- Last updated
- 14 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon
- ClinicalTrials.gov ID
- NCT00413101
- Acronym / sponsor ID
- ML20201
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Dec 2006 (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.
This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: epoetin beta [NeoRecormon] |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, 18-75 years of age;
- end-stage renal disease;
- on renal dialysis >= 3 months;
- receiving NeoRecormon treatment >= 3 months;
- Hb stable and <105g/L, and LVMI >160g/m2.
Key exclusion criteria (4 listed)
- unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
- use of any ESA other than NeoRecormon;
- acute infection;
- use of iv NeoRecormon.
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 beta [NeoRecormon]At a dose to achieve and maintain an Hb level of 120-135g/L | Drug | 1 |
Primary outcome
Hb level, BP.
Time frame: Throughout study
LVMI ejection fraction, ejection fraction.
Time frame: 12 months
1 secondary outcome
SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.
Time frame: Throughout study
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 14 May 2009.
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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.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing epoetin beta [NeoRecormon] in people with Anemia, run by Hoffmann-La Roche at 1 site in Serbia.
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 4 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 14 May 2009. 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 Serbia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Hb level, BP. (time frame: Throughout study). 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 14 May 2009.