AnemiaPhase 3NCT00680563
A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 22 sites in 10 countries.
Trial summary
This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 22 sitesin 10 countries
- Study dates
- Apr 2009to Jan 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, >=18 years of age;
- chronic renal anemia;
- no ESA therapy during previous 3 months;
- adequate iron status;
- rapid chronic kidney disease progression.
Who cannot join
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization in previous 6 months;
- significant acute or chronic bleeding.
Trial locations and contacts
22 sites in 10 countries.
22 sites in 10 countries
Brazil6 sites
Study site
Blumenau, 89010-500
Study site
Botucatu, 18618-000
Study site
Curitiba, 80250-070
Study site
Rio de Janeiro, 20551-030
Study site
São Paulo, 01246-903
Study site
São Paulo, 04039-901
Colombia4 sites
Study site
Barranquilla, 575
Study site
Cali, 572
Study site
Envigado, 571
Study site
Medellín, 0
Argentina3 sites
Study site
Buenos Aires, CP2700
Study site
La Plata, 1900
Study site
San Miguel de Tucumán, 4000
About this study
Official title: An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.
This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
sc every month (starting dose 1.2 micrograms/kg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).
Measured: Week 32
Secondary outcomes (5)
Time to achievement of response
Measured: Throughout study
Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL
Measured: Throughout study
Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL
Measured: Throughout study
Mean time spent in Hb range of 10.0 - 12.0g/dL
Measured: Throughout study
Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.
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 posted20 May 2008 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionJan 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680563
- Sponsor's protocol ID
- ML21467
- Status last verified
- Nov 2013
- First submitted
- 16 May 2008
- Last updated
- 5 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.
- ClinicalTrials.gov ID
- NCT00680563
- Acronym / sponsor ID
- ML21467
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 May 2008 (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 assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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: methoxy polyethylene glycol-epoetin beta [Mircera] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, >=18 years of age;
- chronic renal anemia;
- no ESA therapy during previous 3 months;
- adequate iron status;
- rapid chronic kidney disease progression.
Key exclusion criteria (3 listed)
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization in previous 6 months;
- significant acute or chronic bleeding.
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 |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera]sc every month (starting dose 1.2 micrograms/kg) | Drug | 1 |
Primary outcome
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).
Time frame: Week 32
5 secondary outcomes
Time to achievement of response
Time frame: Throughout study
Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL
Time frame: Throughout study
Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL
Time frame: Throughout study
Mean time spent in Hb range of 10.0 - 12.0g/dL
Time frame: Throughout study
Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.
Time frame: Throughout study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
Clinical Trials study director
Hoffmann-La Roche
22 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 22 sites in 10 countries.
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 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: stopped early, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Brazil, Colombia, Argentina, Chile, Peru and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. 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?
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP). (time frame: Week 32). 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 5 Nov 2013.