Anemia, Kidney Disease, ChronicNCT01379963
A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)
An observational study of Anemia, Kidney Disease, Chronic, run by Hoffmann-La Roche at 17 sites in Greece.
Trial summary
This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Kidney Disease, Chronic
- How many people
- 780 participants
- Where
- 17 sitesGreece
- Study dates
- 30 Apr 2009to 28 Feb 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 on treatment with Mircera
Who may be able to join
- Adult patients, >/= 18 years of age
- Renal anemia treated with Mircera for at least 6 months before entering study
Who cannot join
- Patients who refuse or are incapable of giving their written informed consent to retrospective data collection
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Greece17 sites
Timios Stavros Clinic; Nephrology Department
Aigáleo, 12244
General Hospital of Artas; Nephrology
Arta, 47100
Pantokrator Private Clinic; Nephrology
Athens, 10433
Attikon Center; Nephrology
Athens, 11362
Athinaiki Private Clinic
Athens, 11521
Kyanos Stavros Private Hospital; Nephrologic Clinic
Athens, 11528
Iaso General Private Clinic; Nephrology
Athens, 15562
Iatriko Athinon Clinic Dafnis; Nephrology Department
Daphni-athens, 17237
Kyanous Stavros of Patras, Renal Disease Therapy Unit
Pátrai, 26225
Olympion Therapeytirion; Nefrology
Pátrai, 26443
Iasis Private Clinic
Piraeus, 42356
General Hospital Of Chalkidikis; Dialysis Center Unit
Polygyros, 63100
Diavalkaniko Kentro; Nephrology
Thessaloniki, 57001
General Hospital of Thessalonikis G.Papanikolaou; Nephrology
Thessaloniki, 57010
Alfa Nefrodynamiki; Nefrology
Thessaloniki, 57500
Thessaliki Nossileytiki; Nephrology
Volos, 38221
General Hospital of Volos; Nephrology
Volos, 38222
About this study
Official title: Non-interventional Study of Six-month Retrospective Reporting of Hemoglobin Levels in Patients With Renal Anaemia Who Are Treated With MIRCERA® (Methoxy-polyethylene-glycol-epoetin Beta)
This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).
- Conditions
- Anemia, Kidney Disease, Chronic
- Medical subject headings
- Anemia, Kidney Diseases, Bronchiolitis Obliterans Syndrome
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.
Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)
Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
Measured: Up to 6 months
Secondary outcomes (1)
Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL
Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study start30 Apr 2009
- Primary completion28 Feb 2011
- Study completion28 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anemia, Kidney Disease, ChronicStudies 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
- Retrospective
- Enrolment
- 780 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
- NCT01379963
- Sponsor's protocol ID
- ML22014
- Status last verified
- May 2017
- First submitted
- 22 Jun 2011
- Last updated
- 13 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study of Six-month Retrospective Reporting of Hemoglobin Levels in Patients With Renal Anaemia Who Are Treated With MIRCERA® (Methoxy-polyethylene-glycol-epoetin Beta)
- ClinicalTrials.gov ID
- NCT01379963
- Acronym / sponsor ID
- ML22014
- Conditions
- Anemia, Kidney Disease, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2009 (actual)
- Primary completion
- 28 Feb 2011 (actual)
- Study completion
- 28 Feb 2011 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Posted 24 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- 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 on treatment with Mircera
Key inclusion criteria (2 listed)
- Adult patients, >/= 18 years of age
- Renal anemia treated with Mircera for at least 6 months before entering study
Key exclusion criteria (1 listed)
- Patients who refuse or are incapable of giving their written informed consent to retrospective data collection
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
Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)
Time frame: Up to 6 months
Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
1 secondary outcome
Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
17 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, Kidney Disease, Chronic, run by Hoffmann-La Roche at 17 sites in Greece.
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 2 inclusion and 1 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 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Greece. 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?
Yes. Results are posted in the registry (first posted 24 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL) (time frame: Up to 6 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 13 Jul 2017.