AnemiaPhase 3NCT00081484
A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
A Phase 3 study testing epoetin alfa or beta and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 66 sites in 12 countries.
Trial summary
This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- epoetin alfa or beta and methoxy polyethylene glycol-epoetin beta [Mircera]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 66 sitesin 12 countries
- Study dates
- Jun 2004to Mar 2006
- 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;
- on dialysis therapy for at least 12 weeks before screening;
- receiving iv or sc epoetin for at least 8 weeks before screening.
Who cannot join
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or during the study period.
Trial locations and contacts
66 sites in 12 countries.
66 sites in 12 countries
United States31 sites
Study site
Baton Rouge, Louisiana, 70884
Study site
Boston, Massachusetts, 02135
Study site
Charlottesville, Virginia, 22908
Study site
Cleveland, Ohio, 44109
Study site
Cleveland, Ohio, 44195
Study site
Columbia, South Carolina, 29209
Study site
Columbus, Mississippi, 39705
Study site
Covina, California, 91723
Study site
Erie, Pennsylvania, 16502
Study site
Flushing, New York, 11355
Study site
Hackensack, New Jersey, 07601
Study site
Honolulu, Hawaii, 96813
Study site
Kalamazoo, Michigan, 49007
Study site
Lewistown, Pennsylvania, 17044
Study site
Los Alamitos, California, 90720
Study site
Los Angeles, California, 90073
Study site
New York, New York, 10025
Study site
Norfolk, Virginia, 23507-1901
Study site
Orchard Park, New York, 14127
Study site
Oregon City, Oregon, 97045
Study site
Philadelphia, Pennsylvania, 19106
Study site
Philadelphia, Pennsylvania, 19140
Study site
Philadelphia, Pennsylvania, 19141
Study site
San Diego, California, 92123
Study site
San Diego, California, 92161
Study site
Shreveport, Louisiana, 71101
Study site
Shreveport, Louisiana, 71103
Study site
South Holland, Illinois, 60473
Study site
St Louis, Missouri, 63128
Study site
Tampa, Florida, 33617
Study site
Tupelo, Mississippi, 38801
France7 sites
Study site
Aix-en-Provence, 13616
Study site
Chambéry, 73011
Study site
Hyères, 83400
Study site
Le Kremlin-Bicêtre, 94275
Study site
Nantes, 44093
Study site
Paris, 75970
Study site
Rouen, 76031
United Kingdom5 sites
Study site
Glasgow, G4 OSF
Study site
Hertford, SG1 4AB
Study site
London, E1 1BB
Study site
Salford, M6 8HD
Study site
Swansea, SA6 6NL
Canada4 sites
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Montreal, Quebec, H3G 1A4
Study site
Ottawa, Ontario, K1H 7W9
Study site
Toronto, Ontario, M5G 2C4
Germany3 sites
Study site
Erlangen, 91054
Study site
München, 80804
Study site
Nuremberg, 90431
Italy3 sites
Study site
Como, 22100
Study site
Modena, 41100
Study site
Pavia, 27100
Portugal3 sites
Study site
Carnaxide, 2799-523
Study site
Porto, 4099-001
Study site
Setúbal, 2910-446
Taiwan3 sites
Study site
Kaohsiung City, 833
Study site
Taichung, 407
Study site
Taipei, 100
About this study
Official title: A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease
This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- epoetin alfa or beta, 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.
epoetin alfa or betaDrug
iv or sc, as prescribed
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| 2 | Active comparator | Not described Receives: Drug: epoetin alfa or beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin concentration
Measured: Weeks 1-36
Secondary outcomes (3)
Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration
Measured: Weeks 29-36
RBC transfusions
Measured: Weeks 1-36
AEs, laboratory parameters, vital signs
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 posted16 Apr 2004 (estimated)
- Study startJun 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 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
- NCT00081484
- Sponsor's protocol ID
- BA17284
- Status last verified
- Nov 2016
- First submitted
- 13 Apr 2004
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280
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
- A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00081484
- Acronym / sponsor ID
- BA17284
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 16 Apr 2004 (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 study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| 2 | Active comparator | Drug: epoetin alfa or beta |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving iv or sc epoetin for at least 8 weeks before screening.
Key exclusion criteria (2 listed)
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or during the study period.
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 |
|---|---|---|
| epoetin alfa or betaiv or sc, as prescribed | Drug | 2 |
| methoxy polyethylene glycol-epoetin beta [Mircera]30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks | Drug | 1 |
Primary outcome
Change in hemoglobin concentration
Time frame: Weeks 1-36
3 secondary outcomes
Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration
Time frame: Weeks 29-36
RBC transfusions
Time frame: Weeks 1-36
AEs, laboratory parameters, vital signs
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 2 Nov 2016.
- Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
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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
66 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa or beta and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 66 sites in 12 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 4 inclusion and 2 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 66 sites in United States, France, United Kingdom, Canada, Germany and 7 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 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?
Change in hemoglobin concentration (time frame: Weeks 1-36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00081484, which also lists 1 linked publication.
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.