AnemiaPhase 3NCT00081471
A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
A Phase 3 study testing darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 98 sites in 13 countries.
Trial summary
This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 98 sitesin 13 countries
- Study dates
- Jun 2004to Jul 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 kidney disease;
- anemia;
- not on dialysis therapy;
- not receiving epoetin.
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
98 sites in 13 countries.
98 sites in 13 countries
United States22 sites
Study site
Allentown, Pennsylvania, 18103
Study site
Austin, Texas, 78705
Study site
Bay Pines, Florida, 33744
Study site
Boston, Massachusetts, 02135
Study site
Boston, Massachusetts, 02215
Study site
Burlington, Vermont, 05401
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Cincinnati, Ohio, 45220
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Columbia, South Carolina, 29209
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Dallas, Texas, 75216
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Detroit, Michigan, 48236
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Flushing, New York, 11355
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Houston, Texas, 77054
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Los Angeles, California, 90073
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Mather, California, 95655
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Morgantown, West Virginia, 26506
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Nashville, Tennessee, 37232
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Ocala, Florida, 34471
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Portland, Oregon, 97201-2940
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Salem, Virginia, 24153
Study site
Shreveport, Louisiana, 71101
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Stamford, Connecticut, 06902
Study site
Stanford, California, 94305-5114
Canada15 sites
Study site
Calgary, Alberta, T2N 2T9
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Edmonton, Alberta, T6G 2B7
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Kamloops, British Columbia, V2C 2T1
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Kitchener, Ontario, N2G 1N9
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London, Ontario, N6A 5A5
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H3A 1A1
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New Westminster, British Columbia, V3L 3W7
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Saskatoon, Saskatchewan, S7K 1N4
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Scarborough Village, Ontario, M1H 3G4
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St. John's, Newfoundland and Labrador, A1B 3V6
Study site
Toronto, Ontario, M4N 3M5
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Toronto, Ontario, M5G 2C4
Study site
Vancouver, British Columbia, V6Z 1Y6
Study site
Winnipeg, Manitoba, R2H 2A6
France13 sites
Study site
Angers, 49933
Study site
Besançon, 25030
Study site
Chartres, 28000
Study site
Colmar, 68024
Study site
Lille, 59037
Study site
Lyon, 69437
Study site
Nantes, 44035
Study site
Paris, 75743
Study site
Paris, 75908
Study site
Perpignan, 66046
Study site
Salouël, 80480
Study site
Toulouse, 31059
Study site
Vandœuvre-lès-Nancy, 54511
Italy12 sites
Study site
Cagliari, 91034
Study site
Cuneo, 12100
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Genova, 16132
Study site
Lecco, 23900
Study site
Lodi, 26900
Study site
Modena, 41100
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Naples, 80131
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Padova, 35128
Study site
Pavia, 27100
Study site
Prato, 50047
Study site
Reggio Calabria, 89124
Study site
Roma, 00184
Spain8 sites
Study site
Almería, 04009
Study site
Barcelona, 08907
Study site
Lleida, 25198
Study site
Madrid, 28041
Study site
Madrid, 28046
Study site
Madrid, 28805
Study site
Palma de Mallorca, 07014
Study site
Valencia, 46017
Germany6 sites
Study site
Aschaffenburg, 63741
Study site
Berlin, 13353
Study site
Bonn, 53127
Study site
Dortmund, 44263
Study site
Düsseldorf, 40225
Study site
Tübingen, 72076
United Kingdom6 sites
Study site
Birmingham, B9 5SS
Study site
Carshalton, SM5 1AA
Study site
Leicester, LE5 4PW
Study site
London, SE1 9RT
Study site
London, SE22 8PT
Study site
London, SW17 0RE
Greece5 sites
Study site
Alexandroupoli, 68100
Study site
Athens, 11527
Study site
Ioannina, 455 00
Study site
Piraeus, 18536
Study site
Thessaloniki, 54629
Australia4 sites
Study site
Clayton, 3186
Study site
Liverpool, 1871
Study site
Parkville, 3052
Study site
Perth, 6847
About this study
Official title: A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease
This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- darbepoetin alfa, 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.
darbepoetin alfaDrug
0.45 micrograms/kg sc (starting dose) weekly
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
0.6 micrograms/kg sc (starting dose) once 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: darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin response rate
Measured: Weeks 1-28
Secondary outcomes (1)
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n
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 completionJul 2006
- Study completionJul 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
- 324 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
- NCT00081471
- Sponsor's protocol ID
- BA16738
- 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 Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00081471
- Acronym / sponsor ID
- BA16738
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 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 subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years 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: darbepoetin alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients >=18 years of age;
- chronic kidney disease;
- anemia;
- not on dialysis therapy;
- not receiving epoetin.
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 |
|---|---|---|
| darbepoetin alfa0.45 micrograms/kg sc (starting dose) weekly | Drug | 2 |
| methoxy polyethylene glycol-epoetin beta [Mircera]0.6 micrograms/kg sc (starting dose) once every 2 weeks | Drug | 1 |
Primary outcome
Hemoglobin response rate
Time frame: Weeks 1-28
1 secondary outcome
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n
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
98 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 98 sites in 13 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 5 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 98 sites in United States, Canada, France, Italy, Spain and 8 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?
Hemoglobin response rate (time frame: Weeks 1-28). 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 NCT00081471, 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.