AnemiaPhase 3NCT00642967
A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
A Phase 3 study testing Methoxy Polyethylene Glycol-epoetin Beta in people with Anemia, run by Hoffmann-La Roche at 69 sites in France.
Trial summary
This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 69 sitesFrance
- Study dates
- Jun 2008to Aug 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
- chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
- continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.
Who cannot join
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding;
- poorly controlled hypertension.
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
France69 sites
Study site
Aix-en-Provence, 13090
Study site
Angers, 49000
Study site
Angers, 49933
Study site
Annonay, 07103
Study site
Avignon, 84902
Study site
Bastia, 20604
Study site
Beauvais, 60000
Study site
Besançon, 25030
Study site
Bois-Guillaume, 76233
Study site
Bordeaux, 33077
Study site
Boulogne-sur-Mer, 62321
Study site
Bourg-en-Bresse, 01012
Study site
Bourges, 18020
Study site
Brest, 29609
Study site
Caen, 14033
Study site
Chalon-sur-Saône, 71100
Study site
Chartres, 28000
Study site
Cherbourg Octeville, 50102
Study site
Cholet, 49300
Study site
Clermont-Ferrand, 63058
Study site
Colmar, 68024
Study site
Creil, 60100
Study site
Créteil, 94010
Study site
Dieppe, 76202
Study site
Évreux, 27023
Study site
Greize, 69400
Study site
Harfleur, 76700
Study site
La Garenne-Colombes, 92250
Study site
La Tronche, 38701
Study site
Le Havre, 76083
Study site
Le Mans, 72037
Study site
Lille, 59042
Study site
Limoges, 87042
Study site
Lyon, 69437
Study site
Maubeuge, 59604
Study site
Metz, 57045
Study site
Metz-Tessy, 74370
Study site
Montluçon, 03108
Study site
Montpellier, 34097
Study site
Montpellier, 34295
Study site
Nancy, 54100
Study site
Nice, 06002
Study site
Nîmes, 30006
Study site
Orléans, 45000
Study site
Paris, 75018
Study site
Paris, 75651
Study site
Paris, 75743
Study site
Paris, 75908
Study site
Paris, 75970
Study site
Pierre-Bénite, 69495
Study site
Poitiers, 86021
Study site
Quimper, 29000
Study site
Roubaix, 59056
Study site
Saint-Brieuc, 22027
Study site
Saint-Laurent-du-Var, 06721
Study site
Saint-Lô, 50009
Study site
Saint-Michel, 16470
Study site
Saint-Nazaire, 44606
Study site
Salouël, 80480
Study site
Sens, 89108
Study site
St-Malo, 35043
Study site
Strasbourg, 67091
Study site
Suresnes, 92151
Study site
Thionville, 57126
Study site
Toulouse, 31059
Study site
Tournan-en-Brie, 77220
Study site
Valenciennes, 59300
Study site
Vandœuvre-lès-Nancy, 54511
Study site
Vannes, 56017
About this study
Official title: A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis
This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.
- Conditions
- Anemia
- Being tested
- Methoxy Polyethylene Glycol-epoetin Beta
- 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 BetaDrug
Also called Mircera, C.E.R.A
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
| Study group | Role | What they receive |
|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Experimental | Participants will receive subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. Receives: Drug: Methoxy Polyethylene Glycol-epoetin Beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period
Measured: Weeks 16-24
Secondary outcomes (4)
Mean change in Hb concentration
Measured: Between reference and Efficacy Evaluation Period
Mean time spent in Hb range
Measured: Weeks 16-24
% patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions
Measured: Weeks 16-48
AEs, lab parameters
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 posted25 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2010
- Study completionAug 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 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
- NCT00642967
- Sponsor's protocol ID
- ML21146
- Other IDs
- 2007-005757-28
- Status last verified
- Sep 2021
- First submitted
- 19 Mar 2008
- Last updated
- 14 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis
- ClinicalTrials.gov ID
- NCT00642967
- Acronym / sponsor ID
- ML21146
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Mar 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 monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Experimental | Drug: Methoxy Polyethylene Glycol-epoetin BetaParticipants will receive subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
- continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.
Key exclusion criteria (3 listed)
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding;
- poorly controlled hypertension.
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 BetaAlso: Mircera, C.E.R.AMethoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. | Drug | Methoxy Polyethylene Glycol-epoetin Beta |
Primary outcome
Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period
Time frame: Weeks 16-24
4 secondary outcomes
Mean change in Hb concentration
Time frame: Between reference and Efficacy Evaluation Period
Mean time spent in Hb range
Time frame: Weeks 16-24
% patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions
Time frame: Weeks 16-48
AEs, lab parameters
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 Sep 2021.
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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
69 sites in 1 country: 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 in people with Anemia, run by Hoffmann-La Roche at 69 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 2 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: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 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.
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 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 maintaining average Hb concentration within target range of 10-12g/dL during evaluation period (time frame: Weeks 16-24). 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 Sep 2021.