AnemiaPhase 3NCT00462384

A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.

A Phase 3 study testing Methoxy Polyethylene Glycol-epoetin Beta in people with Anemia, run by Hoffmann-La Roche at 22 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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: 39 participants
Where: 22 sitesin 4 countries
Study dates: Feb 2008to Apr 2011
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

chronic kidney disease, stage 3 or 4;
anemia (baseline hemoglobin between 9 and 11 grams per deciliter [g/dL]).

Who cannot join

previous therapy with ESA within 12 weeks prior to screening;
significant acute or chronic bleeding such as overt gastrointestinal bleeding;
red blood cell transfusions within 8 weeks before screening;
active malignant disease (except non-melanoma skin cancer).

Trial locations and contacts

22 sites in 4 countries.

Country

City, postcode or hospital

22 sites in 4 countries

Finland8 sites

Study site
HUS, 00029
Study site
Joensuu, 80210
Study site
Jyväskylä, 40620
Study site
Kajaani, 87140
Study site
Kotka, 48210
Study site
Porvoo, 06151
Study site
Tampere, 33521
Study site
Turku, 20521

Other trials in Finland

Latvia6 sites

Study site
Jūrmala, LV2015
Study site
Liepāja, 3402
Study site
Riga, 1002
Study site
Riga, LV1038
Study site
Valmiera, 4201
Study site
Ventspils, LV 3601

Other trials in Latvia

Norway5 sites

Study site
Hønefoss, 3504
Study site
Lillehammer, 2629
Study site
Oslo, 0407
Study site
Stavanger, 4011
Study site
Trondheim, 7006

Other trials in Norway

Estonia3 sites

Study site
Tallinn, 10617
Study site
Tallinn, 13419
Study site
Tartu, 51014

Other trials in Estonia

About this study

Official title: An Open-label, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram [mcg/kg]). 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
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, RO0503821
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.

Study groups in NCT00462384
Study group	Role	What they receive
Methoxy Polyethylene Glycol-epoetin Beta	Experimental	Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value. Receives: Drug: Methoxy Polyethylene Glycol-epoetin Beta

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.
Measured: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)

Secondary outcomes (4)

Time to Achievement of Response
Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.
Measured: Baseline to Week 40
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.
Measured: EEP (Weeks 29 to 36)
Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.
Measured: EEP (Weeks 29 to 36)
Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.
Measured: EEP (Weeks 29 to 36)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Apr 2011

First posted19 Apr 2007 (estimated)
Study startFeb 2008
Primary completionApr 2011
Study completionApr 2011

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00462384
Sponsor's protocol ID: ML20659
Status last verified: Mar 2016
First submitted: 18 Apr 2007
Last updated: 1 Apr 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
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Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
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RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT00462384
Acronym / sponsor ID: ML20659
Conditions: Anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic decision unrelated to safety or efficacy
Enrolment: 39 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 19 Apr 2007 (estimated)
Results: Posted 1 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 BetaMethoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

chronic kidney disease, stage 3 or 4;
anemia (baseline hemoglobin between 9 and 11 grams per deciliter [g/dL]).

Key exclusion criteria (4 listed)

previous therapy with ESA within 12 weeks prior to screening;
significant acute or chronic bleeding such as overt gastrointestinal bleeding;
red blood cell transfusions within 8 weeks before screening;
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 BetaAlso: Mircera, RO0503821Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.	Drug	Methoxy Polyethylene Glycol-epoetin Beta

Primary outcome

Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
Time frame: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)
The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.

4 secondary outcomes

Time to Achievement of Response
Time frame: Baseline to Week 40
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP
Time frame: EEP (Weeks 29 to 36)
Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP
Time frame: EEP (Weeks 29 to 36)
Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP
Time frame: EEP (Weeks 29 to 36)

Results and safety

Results posted to the registry on 1 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Methoxy Polyethylene Glycol-epoetin Beta	39	30

Primary outcome: Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)

Time frame: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36). Mean (Standard Deviation). Unit: grams per deciliter (g/dL)

Measure	Methoxy Polyethylene Glycol-epoetin Beta n = 39
Value	1.32 (0.88)

Population analysed: Intent to treat (ITT) population: included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom data for at least one study variable was available.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 40. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methoxy Polyethylene Glycol-epoetin Beta	11 of 39 (28.2%)	11 of 39 (28.2%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated early due to strategic decision unrelated to safety or efficacy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

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

22 sites in 4 countries: 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 in people with Anemia, run by Hoffmann-La Roche at 22 sites in 4 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 2 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: stopped early, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Finland, Latvia, Norway, Estonia. 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 1 Apr 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?

Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP) (time frame: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00462384.

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 1 Apr 2016.