AnemiaPhase 3NCT00442793
A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
A Phase 3 study testing Epoetin beta and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 14 sites in 2 countries.
Trial summary
This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. 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 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
- 265 participants
- Where
- 14 sitesin 2 countries
- Study dates
- May 2007to May 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
- adult patients, >=18 years of age;
- chronic renal anemia requiring dialysis;
- maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
- adequate iron status.
Who cannot join
- previous epoetin treatment within 8 weeks prior to screening;
- failing renal graft in place;
- bleeding episode necessitating transfusion within 8 weeks prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
China13 sites
Study site
Beijing, 100050
Study site
Beijing, 10029
Study site
Beijing, 100853
Study site
Chengdu, 610072
Study site
Guangzhou, 510515
Study site
Guangzhou
Study site
Hangzhou, 310003
Study site
Nanjing, 210009
Study site
Shanghai, 200001
Study site
Shanghai, 200003
Study site
Shanghai, 200025
Study site
Shanghai, 200032
Study site
Shanghai, 200040
About this study
Official title: A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis
This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- Epoetin 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 betaDrug
As prescribed, 3 times weekly
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
0.4 micrograms/kg iv 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 beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb response rate
Measured: Weeks 0-24
Change in Hb concentration between baseline and evaluation period
Measured: Months 4-6
Secondary outcomes (5)
Hb over time
Measured: Throughout study
Time to Hb response
Measured: Throughout study
RBC transfusions
Measured: Weeks 0-24
AEs, laboratory parameters, vital signs
Measured: Throughout study
Serum concentration of Mircera
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 posted2 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2010
- Study completionMay 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 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
- NCT00442793
- Sponsor's protocol ID
- ML20680
- Status last verified
- Nov 2016
- First submitted
- 1 Mar 2007
- 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
- A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis
- ClinicalTrials.gov ID
- NCT00442793
- Acronym / sponsor ID
- ML20680
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Mar 2007 (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 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). 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 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 requiring dialysis;
- maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
- adequate iron status.
Key exclusion criteria (5 listed)
- previous epoetin treatment within 8 weeks prior to screening;
- failing renal graft in place;
- bleeding episode necessitating transfusion within 8 weeks prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
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 betaAs prescribed, 3 times weekly | Drug | 2 |
| methoxy polyethylene glycol-epoetin beta [Mircera]0.4 micrograms/kg iv every 2 weeks | Drug | 1 |
Primary outcome
Hb response rate
Time frame: Weeks 0-24
Change in Hb concentration between baseline and evaluation period
Time frame: Months 4-6
5 secondary outcomes
Hb over time
Time frame: Throughout study
Time to Hb response
Time frame: Throughout study
RBC transfusions
Time frame: Weeks 0-24
AEs, laboratory parameters, vital signs
Time frame: Throughout study
Serum concentration of Mircera
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.
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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
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin beta and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 14 sites in 2 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 5 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 14 sites in China, Hong Kong. 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?
Hb response rate (time frame: Weeks 0-24). The study lists 2 primary outcomes in all. 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.