AnemiaPhase 4NCT00922116
A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
A Phase 4 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 10 sites in South Korea.
Trial summary
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4… 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 [Mircera]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 30 Apr 2009to 30 Nov 2010
- Phase
- Phase 4
- 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 renal anemia;
- continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.
Who cannot join
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease (except non-melanoma skin cancer).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Inje University Busan Paik Hospital; Nephrology
Busan, 633-165
Kyungpook National Uni Hospital; Internal Medicine
Daegu, 700-721
Chungnam National Uni Hospital; Nephrology
Daejeon, 301-721
Chonnam National University Hospital
Gwangju, 61469
NHIC Ilsan Hospital
Kyonggi-do, 411-719
Seoul National Uni Hospital; Internal Medicine
Seoul, 03080
Seoul St Mary's Hospital
Seoul, 06591
Severance Hospital; Division of Nephrology
Seoul, 120-752
East-West Neo Medical Center; Division Of Nephology
Seoul, 134-837
Samsung Medical Centre; Department of Hematology & Oncology
Seoul, 135-710
About this study
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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 [Mircera]
- 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 beta [Mircera]Drug
sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
Measured: EEP (Weeks 17 to 24)
Secondary outcomes (5)
Change in Hemoglobin Concentration Between SVP and the EEP
Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.
Measured: SVP (Baseline), and EEP (Weeks 17 to 24)
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP
EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.
Measured: EEP (Weeks 17 to 24)
Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Measured: Weeks 1 to 24
Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Measured: Weeks 1 to 24
Average Dose of Mircera Per Month
Measured: Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study start30 Apr 2009
- Primary completion30 Nov 2010
- Study completion30 Nov 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 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
- NCT00922116
- Sponsor's protocol ID
- ML22285
- Status last verified
- May 2017
- First submitted
- 16 Jun 2009
- Last updated
- 13 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis
- ClinicalTrials.gov ID
- NCT00922116
- Acronym / sponsor ID
- ML22285
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2009 (actual)
- Primary completion
- 30 Nov 2010 (actual)
- Study completion
- 30 Nov 2010 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Posted 9 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients, >=18 years of age;
- chronic renal anemia;
- continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.
Key exclusion criteria (4 listed)
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease (except non-melanoma skin cancer).
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 beta [Mircera]sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy) | Drug | 1 |
Primary outcome
Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
Time frame: EEP (Weeks 17 to 24)
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
5 secondary outcomes
Change in Hemoglobin Concentration Between SVP and the EEP
Time frame: SVP (Baseline), and EEP (Weeks 17 to 24)
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP
Time frame: EEP (Weeks 17 to 24)
Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP
Time frame: Weeks 1 to 24
Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP
Time frame: Weeks 1 to 24
Average Dose of Mircera Per Month
Time frame: Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- 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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 10 sites in South Korea.
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 3 inclusion and 4 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 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Dec 2015). 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 Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) (time frame: EEP (Weeks 17 to 24)). 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 13 Jul 2017.