AnemiaPhase 3NCT00422513
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta and Epoetin alfa in people with Anemia, run by Hoffmann-La Roche at 44 sites in United States.
Trial summary
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. 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 and Epoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 44 sitesUnited States
- Study dates
- Mar 2007to Dec 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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;
- CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;
- CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;
- average hemoglobin (Hb) 10-12 g/dL over last 3 months.
Who cannot join
- failed renal transplant within 12 months prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Study site
Augusta, Georgia
Study site
Birmingham, Alabama
Study site
Brandon, Florida
Study site
Brooklyn, New York
Study site
Brooklyn Center, New York
Study site
Chesapeake, Virginia
Study site
Columbia, South Carolina
Study site
Corpus Christi, Texas
Study site
Detroit, Michigan
Study site
Fairfax, Virginia
Study site
Fairfield, California
Study site
Flushing, New York
Study site
Fort Wayne, Indiana
Study site
Gurnee, Illinois
Study site
Hot Springs, Arizona
Study site
Houston, Texas
Study site
Hudson, Florida
Study site
Lakewood, Colorado
Study site
Lancaster, Pennsylvania
Study site
Lauderdale Lakes, Florida
Study site
Lewistown, Pennsylvania
Study site
Los Alamitos, California
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Mountain View, California
Study site
New Brunswick, New Jersey
Study site
Ocala, Florida
Study site
Orangeburg, South Carolina
Study site
Orchard Park, New York
Study site
Palm Beach Gardens, Florida
Study site
Philadelphia, Pennsylvania
Study site
Pontiac, Michigan
Study site
Rainbow City, Alabama
Study site
Raleigh, North Carolina
Study site
Riverside, California
Study site
San Diego, California
Study site
Simi Valley, California
Study site
Sparks, Nevada
Study site
The Bronx, New York
Study site
Toledo, Ohio
Study site
Tulsa, Oklahoma
Study site
West Homestead, Pennsylvania
Study site
Whittier, California
Study site
Williamsville, New York
About this study
Official title: A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- methoxy polyethylene glycol-epoetin beta, Epoetin alfa
- 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
120-360 micrograms intravenous (iv) monthly, starting dose
Epoetin alfaDrug
As prescribed, iv, 3 times weekly
| Study group | Role | What they receive |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Experimental | 120-360 micrograms (iv) monthly, starting dose Receives: Drug: methoxy polyethylene glycol-epoetin beta |
| Epoetin Alfa | Active comparator | As prescribed, (iv), 3 times weekly Receives: Drug: Epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent on Anemia Treatment Over Evaluation Period
Efficacy and pharmacoeconomics analyses were not performed.
Measured: Months 5-7
Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period
Efficacy and pharmacoeconomics analyses were not performed.
Measured: Baseline, Months 5-7
Secondary outcomes (2)
Number of Participants Assessed for AEs
The adverse events are captured in the adverse event and serious adverse event section of this database.
Measured: Month 1 to 15 day follow up post month 7
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.
Measured: Baseline, Month 1 to Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Strategic decision unrelated to safety or efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 260 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
- NCT00422513
- Sponsor's protocol ID
- ML20336
- Status last verified
- Nov 2011
- First submitted
- 15 Jan 2007
- Last updated
- 14 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.
- ClinicalTrials.gov ID
- NCT00422513
- Acronym / sponsor ID
- ML20336
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision unrelated to safety or efficacy
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Jan 2007 (estimated)
- Results
- Posted 14 Dec 2011
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 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. 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 |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Experimental | Drug: methoxy polyethylene glycol-epoetin beta120-360 micrograms (iv) monthly, starting dose |
| Epoetin Alfa | Active comparator | Drug: Epoetin alfaAs prescribed, (iv), 3 times weekly |
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;
- CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;
- CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;
- average hemoglobin (Hb) 10-12 g/dL over last 3 months.
Key exclusion criteria (3 listed)
- failed renal transplant within 12 months 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 |
|---|---|---|
| methoxy polyethylene glycol-epoetin betaAlso: Mircera120-360 micrograms intravenous (iv) monthly, starting dose | Drug | methoxy polyethylene glycol-epoetin beta |
| Epoetin alfaAs prescribed, iv, 3 times weekly | Drug | Epoetin Alfa |
Primary outcome
Time Spent on Anemia Treatment Over Evaluation Period
Time frame: Months 5-7
Efficacy and pharmacoeconomics analyses were not performed.
Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period
Time frame: Baseline, Months 5-7
Efficacy and pharmacoeconomics analyses were not performed.
2 secondary outcomes
Number of Participants Assessed for AEs
Time frame: Month 1 to 15 day follow up post month 7
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Time frame: Baseline, Month 1 to Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
44 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 and Epoetin alfa in people with Anemia, run by Hoffmann-La Roche at 44 sites in United States.
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 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: stopped early, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. 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?
Yes. Results are posted in the registry (first posted 14 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Spent on Anemia Treatment Over Evaluation Period (time frame: Months 5-7). 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 14 Dec 2011.