AnemiaPhase 4NCT00642668
A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
A Phase 4 study testing methoxy polyethylene glycol-epoetin beta in people with Anemia, run by Hoffmann-La Roche at 32 sites in Belgium.
Trial summary
This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 32 sitesBelgium
- Study dates
- 30 Jun 2008to 31 Dec 2009
- 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 participants, >=18 years of age;
- Chronic renal anemia;
- No ESA therapy during previous 3 months.
Who cannot join
- Transfusion of red blood cells during previous 2 months;
- Poorly controlled hypertension requiring hospitalization in previous 6 months;
- Significant acute or chronic bleeding.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Belgium32 sites
ASZ Aalst
Aalst, 9300
ZNA Middelheim
Antwerp, 2020
ZNA Stuivenberg
Antwerp, 2060
AZ Sint Lucas Brugge
Assebroek, 8310
CH EpiCURA Site Ath
Ath, 7800
CH EpiCURA Site Louis Caty
Baudour, 7331
Imeldaziekenhuis
Bonheiden, 2820
Clinique Saint-Jean- Botanique
Brussels, 1000
CHU Brugmann (Victor Horta)
Brussels, 1020
Clin Univ de Bxl Hôpital Erasme
Brussels, 1070
HIS (Joseph Bracops)
Brussels, 1070
UZ Brussel
Brussels, 1090
CHIREC Edith Cavell
Brussels, 1180
Cliniques Universitaires St-Luc
Brussels, 1200
CHU de Charleroi
Charleroi, 6000
AZ Sint Blasius (Dendermonde)
Dendermonde, 9200
UZ Antwerpen
Edegem, 2650
ZOL (Sint Jan)
Genk, 3600
AZ Sint Lucas (Sint Lucas)
Ghent, 9000
UZ Gent
Ghent, 9000
CH EpiCURA Site Hornu
Hornu, 7301
CHR Hutois
Huy, 4500
Jan Yperman Onze Lieve Vrouw
Ieper, 8900
UZ Leuven Gasthuisberg
Leuven, 3000
Chr de La Citadelle
Liège, 4000
CHU Sart-Tilman
Liège, 4000
Clinique Saint-Joseph
Liège, 4000
AZ Delta (Campus Wilgenstraat)
Roeselare, 8800
AZ Nikolaas (Sint Niklaas)
Sint-Niklaas, 9100
CHWapi site IMC
Tournai, 7500
AZ Turnhout Sint Jozef
Turnhout, 2300
CHR de Verviers - East Belgium
Verviers, 4800
About this study
Official title: Subcutaneous Treatment of Anemia in Patients With a GFR Below 45 ml/Min/1.73m2 Through Injections With Mircera as Low Frequent as Once Monthly (STABILO)
This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.
- Conditions
- Anemia
- Being tested
- methoxy polyethylene glycol-epoetin beta
- 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
1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
| Study group | Role | What they receive |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Experimental | Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period. Receives: Drug: methoxy polyethylene glycol-epoetin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range
The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.
Measured: Weeks 29-36
Secondary outcomes (4)
Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)
The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.
Measured: Weeks 0-36
Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)
Measured: Weeks 29-36
Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)
Measured: Weeks 29-36
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: Weeks 1-40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study start30 Jun 2008
- Primary completion31 Dec 2009
- Study completion31 Dec 2009
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
- 35 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
- NCT00642668
- Sponsor's protocol ID
- ML21348
- Status last verified
- May 2017
- First submitted
- 19 Mar 2008
- Last updated
- 5 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 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Treatment of Anemia in Patients With a GFR Below 45 ml/Min/1.73m2 Through Injections With Mircera as Low Frequent as Once Monthly (STABILO)
- ClinicalTrials.gov ID
- NCT00642668
- Acronym / sponsor ID
- ML21348
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2008 (actual)
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 22 Jul 2016
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 assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Experimental | Drug: methoxy polyethylene glycol-epoetin betaParticipants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period. |
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 participants, >=18 years of age;
- Chronic renal anemia;
- No ESA therapy during previous 3 months.
Key exclusion criteria (3 listed)
- Transfusion of red blood cells during previous 2 months;
- Poorly controlled hypertension requiring hospitalization in previous 6 months;
- Significant acute or chronic bleeding.
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: Mircera1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose) | Drug | Methoxy Polyethylene Glycol-Epoetin Beta |
Primary outcome
Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range
Time frame: Weeks 29-36
The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.
4 secondary outcomes
Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)
Time frame: Weeks 0-36
Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)
Time frame: Weeks 29-36
Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)
Time frame: Weeks 29-36
Percentage of Participants With Adverse Events
Time frame: Weeks 1-40
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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
32 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 in people with Anemia, run by Hoffmann-La Roche at 32 sites in Belgium.
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 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: finished, as of the sponsor's last update on 5 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 32 sites in Belgium. 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 22 Jul 2016). 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 During Efficacy Evaluation Period (EEP) Within Target Range (time frame: Weeks 29-36). 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 5 Jul 2017.