AnemiaNCT01690455
An Observational Study of Mircera in Renal Anemia Correction In Dialysed Patients During Daily Clinical Practice
An observational study of Anemia, run by Hoffmann-La Roche at 33 sites in Poland.
Trial summary
This observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera according to local summary of product characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- How many people
- 247 participants
- Where
- 33 sitesPoland
- Study dates
- Jul 2011to Jun 2015
- Phase
- Observational
- 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
Study population: Patients with renal anemia and on dialysis therapy
Who may be able to join
- Adult patients, >/=18 years of age
- Adequate iron status
- Signed informed consent form
Who cannot join
- Anemia due to non-renal causes
- Where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer)
- Pregnant or lactating female patients
- Any contraindications against treatment with Mircera (according to local Summary of Product Characteristics)
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Poland33 sites
Study site
Bartoszyce, 11-200
Study site
Bydgoszcz, 85-681
Study site
Ciechanów, 06-400
Study site
Częstochowa, 42-200
Study site
Dębica, 39-200
Study site
Gliwice, 44-100
Study site
Gmina Świecie, 86-100
Study site
Gorzów Wielkopolski, 64-400
Study site
Grudziądz, 86-300
Study site
Hajnówka, 17-200
Study site
Jastrzębie Zdrój, 44-330
Study site
Jaworzno, 43-600
Study site
Kępno, 63-600
Study site
Konin, 62-504
Study site
Kościerzyna, 83-400
Study site
Łapy, 18-100
Study site
Lodz, 90-153
Study site
Milicz, 56-300
Study site
Piła, 64-920
Study site
Polanica-Zdrój, 57-320
Study site
Radom, 26-610
Study site
Rybnik, 44-200
Study site
Rzeszów, 35-055
Study site
Rzeszów, 35-301
Study site
Sandomierz, 27-600
Study site
Siedlce, 08-110
Study site
Słupsk, 76-200
Study site
Starachowice, 27-200
Study site
Suwałki, 16-400
Study site
Warsaw, 04-141
Study site
Wołomin, 05-200
Study site
Wroclaw, 51-124
Study site
Zgorzelec, 59-900
About this study
Official title: Non-interventional Study to Assess the Efficacy of Mircera for Renal Anemia Correction in Dialysis Patients in Everyday Clinical Practice in Poland.
This observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera according to local summary of product characteristics. Data will be collected for 12 months.
- Conditions
- Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve a hemoglobin level of >/=10 g/dl
Measured: 12 months
Secondary outcomes (1)
Safety: incidence of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionJun 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 247 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
- NCT01690455
- Sponsor's protocol ID
- ML25701
- Status last verified
- Nov 2016
- First submitted
- 19 Sep 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Assess the Efficacy of Mircera for Renal Anemia Correction in Dialysis Patients in Everyday Clinical Practice in Poland.
- ClinicalTrials.gov ID
- NCT01690455
- Acronym / sponsor ID
- ML25701
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Sep 2012 (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 observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera according to local summary of product characteristics. Data will be collected for 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with renal anemia and on dialysis therapy
Key inclusion criteria (3 listed)
- Adult patients, >/=18 years of age
- Adequate iron status
- Signed informed consent form
Key exclusion criteria (4 listed)
- Anemia due to non-renal causes
- Where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer)
- Pregnant or lactating female patients
- Any contraindications against treatment with Mircera (according to local Summary of Product Characteristics)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients who achieve a hemoglobin level of >/=10 g/dl
Time frame: 12 months
1 secondary outcome
Safety: incidence of adverse events
Time frame: 12 months
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 2 Nov 2016.
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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
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Hoffmann-La Roche at 33 sites in Poland.
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 3 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Poland. 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?
Proportion of patients who achieve a hemoglobin level of >/=10 g/dl (time frame: 12 months). 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 2 Nov 2016.