AnemiaNCT01974271
An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)
An observational study of Anemia, run by Hoffmann-La Roche at 76 sites in France.
Trial summary
This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- How many people
- 661 participants
- Where
- 76 sitesFrance
- Study dates
- Jan 2014to Apr 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: Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months, previously treated with an erythropoietin stimulating agent (ESA) and for whom treatment with Mircera is indicated
Who may be able to join
- Adult patients, >/= 18 years of age
- Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months
- Previously treated with an erythropoietin stimulating agent (ESA)
- Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons
- Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL
Who cannot join
- Current participation in a clinical trial on renal anemia
Trial locations and contacts
76 sites in 1 country.
76 sites in 1 country
France76 sites
Study site
Aix-en-Provence, 13616
Study site
Ajaccio, 20303
Study site
Annonay, 07100
Study site
Arras, 62022
Study site
Auch, 32008
Study site
Aurillac, 15013
Study site
Beauvais, 60000
Study site
Beauvais, 60021
Study site
Bois-Bernard, 62320
Study site
Bordeaux, 33000
Study site
Bourg-en-Bresse, 01012
Study site
Bourgoin, 38317
Study site
Brest, 29609
Study site
Chamalières, 63400
Study site
Chaumont, 52001
Study site
Clermont-Ferrand, 63003
Study site
Clermont-Ferrand, 63050
Study site
Colmar, 68024
Study site
Condom, 32100
Study site
Dijon, 21000
Study site
Dourlers, 59440
Study site
Épinal, 88021
Study site
Fleurance, 32500
Study site
Fourmies, 59611
Study site
Gap, 05000
Study site
Gradignan, 33171
Study site
Haguenau, 67504
Study site
La Roche-sur-Yon, 85925
Study site
La Tronche, 38701
Study site
Le Mans, 72037
Study site
Le Puy-en-Velay, 43012
Study site
Libourne, 33505
Study site
Lille, 59042
Study site
Maubeuge, 59607
Study site
Meaux, 77104
Study site
Mirande, 32300
Study site
Montereau, 77871
Study site
Nantes, 44035
Study site
Nantes, 44093
Study site
Neuilly-sur-Seine, 92523
Study site
Nîmes, 30900
Study site
Nogaro, 32110
Study site
Noyal-Pontivy, 56920
Study site
Olivet, 45160
Study site
Orléans, 45100
Study site
Paris, 75 016
Study site
Paris, 75009
Study site
Paris, 75014
Study site
Paris, 75970
Study site
Pessac, 33608
Study site
Poitiers, 86021
Study site
Quimper, 29107
Study site
Quincy-sous-Sénart, 91480
Study site
Rambouillet, 78514
Study site
Rennes, 35033
Study site
Rezé, 44402
Study site
Roubaix, 59100
Study site
Rouen, 76040
Study site
Saint-Brieuc, 22027
Study site
Saint-Laurent-du-Var, 06721
Study site
Saint-Lô, 50009
Study site
Saint-Marcel, 27950
Study site
Saint-Nazaire, 63050
Study site
Saint-Ouen, 93400
Study site
Saint-Priest-en-Jarez, 42277
Study site
Salouël, 80480
Study site
Saran, 45770
Study site
Stains, 93240
Study site
Strasbourg, 67091
Study site
Toulouse, 31059
Study site
Tourcoing, 59200
Study site
Valenciennes, 59300
Study site
Vandœuvre-lès-Nancy, 54511
Study site
Vesoul, 70014
Study site
Villefranche-de-Rouergue, 12200
Study site
Yssingeaux, 43200
About this study
Official title: IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A
This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.
- 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.
Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6
Measured: 6 months
Secondary outcomes (4)
Percentage of patients with Hb value within the range of 10 - 12 g/dL
Measured: 6 months
Change in Hb level
Measured: from baseline to Month 6
Monthly dose of Mircera
Measured: 6 months
Safety: Incidence of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 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
- 661 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
- NCT01974271
- Sponsor's protocol ID
- ML28980
- Status last verified
- Nov 2016
- First submitted
- 28 Oct 2013
- 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
- IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A
- ClinicalTrials.gov ID
- NCT01974271
- Acronym / sponsor ID
- ML28980
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Nov 2013 (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 prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.
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
- Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months, previously treated with an erythropoietin stimulating agent (ESA) and for whom treatment with Mircera is indicated
Key inclusion criteria (5 listed)
- Adult patients, >/= 18 years of age
- Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months
- Previously treated with an erythropoietin stimulating agent (ESA)
- Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons
- Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL
Key exclusion criteria (1 listed)
- Current participation in a clinical trial on renal anemia
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 patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6
Time frame: 6 months
4 secondary outcomes
Percentage of patients with Hb value within the range of 10 - 12 g/dL
Time frame: 6 months
Change in Hb level
Time frame: from baseline to Month 6
Monthly dose of Mircera
Time frame: 6 months
Safety: Incidence of adverse events
Time frame: 6 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
76 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 76 sites in France.
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 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 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 76 sites in France. 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?
Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6 (time frame: 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 2 Nov 2016.