AnemiaPhase 3NCT00642850

STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 24 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 [Mircera]
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 188 participants
Where: 24 sitesCzechia
Study dates: Nov 2007to Jul 2009
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 renal anemia;
Continuous stable intravenous maintenance epoetin therapy during previous month;
Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Who cannot join

Transfusion of red blood cells during previous 2 months;
Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
Significant acute or chronic bleeding.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

Czechia24 sites

Study site
Brno, 656 91
Study site
Český Krumlov, 38127
Study site
Děčín, 405 99
Study site
Havířov, 736 24
Study site
Hradec Králové, 500 05
Study site
Jihlava, 586 33
Study site
Karlovy Vary, 360 73
Study site
Kolin III, 280 20
Study site
Liberec, 460 63
Study site
Nový Jičín, 741 11
Study site
Olomouc, 775 20
Study site
Ostrava, 708 52
Study site
Písek, 397 23
Study site
Prague, 128 08
Study site
Prague, 14000
Study site
Prague, 150 30
Study site
Prague, 169 00
Study site
Strakonice, 38629
Study site
Šumperk, 787 01
Study site
Tábor, 390 03
Study site
Teplice, 415 01
Study site
Třebíč, 674 01
Study site
Ústí nad Labem, 401 13
Study site
Znojmo, 76275

Other trials in Czechia

About this study

Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. 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
120, 200 or 360 micrograms iv monthly (starting dose)

Study groups in NCT00642850
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 +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.
Measured: Week 17 up to Week 24

Secondary outcomes (6)

Change in Hemoglobin Concentration Between Reference (SVP) and EEP
The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.
Measured: Week -4 up to Week -1 and Week 17 up to Week 24
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
Measured: Week 17 up to Week 24
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
Measured: Week 17 up to Week 24
Percentage of Participants Requiring Any Dose Adjustment
Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
Measured: Week 1 to Week 16 and Week 17 to Week 24
Number of Participants With Red Blood Cell Transfusion During the Study
Number of participant who underwent red blood cell transfusion during the study was reported.
Measured: Week -4 up to Week 28
Number of Participants With Anti-epoetin Antibody
Measured: Week -4 and at early withdrawal or Week 28

Timeline

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

Nov 2007Jul 2009

First posted25 Mar 2008 (estimated)
Study startNov 2007
Primary completionJul 2009
Study completionJul 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.
Publications (1)Papers the sponsor has linked to this study.
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: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00642850
Sponsor's protocol ID: ML21040
Status last verified: May 2016
First submitted: 19 Mar 2008
Last updated: 23 Jun 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
PubMed 26965694

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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The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
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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
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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2016. 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 Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
ClinicalTrials.gov ID: NCT00642850
Acronym / sponsor ID: ML21040
Conditions: Anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 25 Mar 2008 (estimated)
Results: Posted 23 Jun 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
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)

Chronic renal anemia;
Continuous stable intravenous maintenance epoetin therapy during previous month;
Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Key exclusion criteria (3 listed)

Transfusion of red blood cells during previous 2 months;
Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
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 beta [Mircera]120, 200 or 360 micrograms iv monthly (starting dose)	Drug	1

Primary outcome

Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
Time frame: Week 17 up to Week 24
Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.

6 secondary outcomes

Change in Hemoglobin Concentration Between Reference (SVP) and EEP
Time frame: Week -4 up to Week -1 and Week 17 up to Week 24
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
Time frame: Week 17 up to Week 24
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Time frame: Week 17 up to Week 24
Percentage of Participants Requiring Any Dose Adjustment
Time frame: Week 1 to Week 16 and Week 17 to Week 24
Number of Participants With Red Blood Cell Transfusion During the Study
Time frame: Week -4 up to Week 28
Number of Participants With Anti-epoetin Antibody
Time frame: Week -4 and at early withdrawal or Week 28

Results and safety

Results posted to the registry on 23 Jun 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
C.E.R.A.	188	155

Primary outcome: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range

Time frame: Week 17 up to Week 24. Number (95% Confidence Interval). Unit: percentage of participants

Measure	C.E.R.A. n = 154
Value	53.3 (45.1 to 61.3)

Population analysed: Per protocol (PP) population included all participants in the safety population with the exception of participants with less than 3 recorded hemoglobin values, missing administrations of C.E.R.A., withdrawal, inadequate iron status in Weeks 16-24.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 28 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
C.E.R.A.	41 of 188 (21.8%)	38 of 188 (20.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26965694Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

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
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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

24 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 [Mircera] in people with Anemia, run by Hoffmann-La Roche at 24 sites in Czechia.

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 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Czechia. 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 23 Jun 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 Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range (time frame: Week 17 up to Week 24). 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 NCT00642850, which also lists 1 linked publication.

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 23 Jun 2016.