AnemiaPhase 3NCT00454246
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta, epoetin alfa and darbepoetin alfa in people with Anemia, run by Hoffmann-La Roche at 78 sites in United States.
Trial summary
This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through 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, epoetin alfa and darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 78 sitesUnited States
- Study dates
- Apr 2007to Feb 2008
- 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;
- chronic kidney disease stage IV not requiring dialysis;
- expected to initiate dialysis within 18 months;
- 15<=Glomerular Filtration Rate (GFR)<=29.
Who cannot join
- failing renal allograft in place;
- acute or chronic bleeding within 8 weeks prior to screening;
- transfusion of red blood cells within 8 weeks prior to screening;
- poorly controlled hypertension;
- immunosuppressive therapy in the 12 weeks prior to screening.
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
United States78 sites
Study site
Alexandria, Virginia
Study site
Appleton, Wisconsin
Study site
Atlanta, Georgia
Study site
Augusta, Georgia
Study site
Bakersfield, California
Study site
Baton Rouge, Louisiana
Study site
Birmingham, Alabama
Study site
Bluefield, West Virginia
Study site
Boston, Massachusetts
Study site
Brooklyn, New York
Study site
Buffalo, New York
Study site
Chattanooga, Tennessee
Study site
Colorado Springs, Colorado
Study site
Columbia, South Carolina
Study site
Columbus, Mississippi
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Dyersburg, Tennessee
Study site
El Dorado, Arkansas
Study site
Erie, Pennsylvania
Study site
Evergreen Park, Illinois
Study site
Fairfax, Virginia
Study site
Flushing, New York
Study site
Fort Wayne, Indiana
Study site
Germantown, Maryland
Study site
Glendale, California
Study site
Granada Hills, California, 91344
Study site
Great Neck, New York
Study site
Greenville, North Carolina
Study site
Greenville, South Carolina
Study site
Hot Springs, Arkansas
Study site
Houston, Texas, 77024
Study site
Lakewood, Colorado
Study site
Lewistown, Pennsylvania
Study site
Los Angeles, California
Study site
Macon, Georgia
Study site
Maimisburg, Ohio
Study site
Meridan, Idaho, 83642
Study site
Miami, Florida
Study site
Milwaukee, Michigan
Study site
Mineola, New York
Study site
Mobile, Alabama
Study site
Morgantown, West Virginia
Study site
Ocala, Florida
Study site
Omaha, Nebraska
Study site
Orange, California
Study site
Orangeburg, South Carolina
Study site
Orlando, Florida
Study site
Palm Beach Gardens, Florida
Study site
Palm Springs, California
Study site
Pembroke Pines, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Providence, Rhode Island
Study site
Raleigh, North Carolina
Study site
Richmond, Virginia
Study site
Riverside, California
Study site
Royal Oak, Michigan
Study site
Salem, Virginia
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Shreveport, Louisiana
Study site
Springfield, Massachusetts
Study site
Springfield Gardens, New York
Study site
St Louis, Missouri
Study site
Stamford, Connecticut
Study site
Syracuse, New York
Study site
Tampa, Florida
Study site
Temple, Texas
Study site
The Bronx, New York
Study site
Toledo, Ohio
Study site
Voorhees Township, New Jersey
Study site
West Orange, New Jersey, 07052
Study site
Wichita, Kansas
Study site
Winston-Salem, North Carolina
Study site
Yuba City, California
About this study
Official title: A Randomized, Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Control in Patients Transitioning From Chronic Kidney Disease Stage 4 Through Dialysis
This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
- Conditions
- Anemia
- Being tested
- methoxy polyethylene glycol-epoetin beta, epoetin alfa, darbepoetin 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
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.
epoetin alfaDrug
Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
darbepoetin alfaDrug
Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Experimental | 120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. Receives: Drug: methoxy polyethylene glycol-epoetin beta |
| Epoetin alfa | Active comparator | Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. Receives: Drug: epoetin alfa |
| Darbepoetin alfa | Active comparator | Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. Receives: Drug: darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL
Efficacy analyses were not performed.
Measured: 6-7 months post initiation of dialysis
Secondary outcomes (2)
Dose Adjustments
Efficacy analyses were not performed.
Measured: 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.
Number of Participants Assessed for AEs and SAEs
The adverse events are captured in the adverse event and serious adverse event section of this database.
Measured: First dose of medication through 15 days post last dose (up to 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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
- 111 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
- NCT00454246
- Sponsor's protocol ID
- ML20337
- Status last verified
- Nov 2011
- First submitted
- 29 Mar 2007
- Last updated
- 16 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Control in Patients Transitioning From Chronic Kidney Disease Stage 4 Through Dialysis
- ClinicalTrials.gov ID
- NCT00454246
- Acronym / sponsor ID
- ML20337
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision unrelated to safety or efficacy
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 30 Mar 2007 (estimated)
- Results
- Posted 16 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 study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Experimental | Drug: methoxy polyethylene glycol-epoetin beta120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
| Epoetin alfa | Active comparator | Drug: epoetin alfaPatients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
| Darbepoetin alfa | Active comparator | Drug: darbepoetin alfaPatients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. |
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 kidney disease stage IV not requiring dialysis;
- expected to initiate dialysis within 18 months;
- 15<=Glomerular Filtration Rate (GFR)<=29.
Key exclusion criteria (5 listed)
- failing renal allograft in place;
- acute or chronic bleeding within 8 weeks prior to screening;
- transfusion of red blood cells within 8 weeks prior to screening;
- poorly controlled hypertension;
- immunosuppressive therapy in the 12 weeks prior to screening.
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: MirceraMethoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month. | Drug | methoxy polyethylene glycol-epoetin beta |
| epoetin alfaStandard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. | Drug | Epoetin alfa |
| darbepoetin alfaStandard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study. | Drug | Darbepoetin alfa |
Primary outcome
Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL
Time frame: 6-7 months post initiation of dialysis
Efficacy analyses were not performed.
2 secondary outcomes
Dose Adjustments
Time frame: 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.
Number of Participants Assessed for AEs and SAEs
Time frame: First dose of medication through 15 days post last dose (up to 8 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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
78 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, epoetin alfa and darbepoetin alfa in people with Anemia, run by Hoffmann-La Roche at 78 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 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: stopped early, as of the sponsor's last update on 16 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 78 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 16 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?
Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL (time frame: 6-7 months post initiation of dialysis). 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 16 Dec 2011.