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AnemiaPhase 3NCT00413894

A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 105 sites in Germany.

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

This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. 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]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
105 sitesGermany
Study dates
Mar 2007to Oct 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 renal anemia;
  • longterm hemodialysis for >=12 weeks before screening;
  • baseline Hb between 10 and 13g/dL;
  • iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening.

Who cannot join

  • acute or chronic bleeding within 8 weeks prior to screening;
  • transfusion of red blood cells within 8 weeks prior to screening;
  • poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
  • previous treatment with Mircera.

Trial locations and contacts

105 sites in 1 country.

105 sites in 1 country

Germany105 sites

  • Study site

    Aachen, 52066

  • Study site

    Aachen, 52074

  • Study site

    Alzey, 55232

  • Study site

    Ansbach, 91522

  • Study site

    Augsburg, 86157

  • Study site

    Bad König, 64732

  • Study site

    Bad Nenndorf, 31542

  • Study site

    Bad Oeynhausen, 32545

  • Study site

    Bad Orb, 63619

  • Study site

    Bayreuth, 95445

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 10249

  • Study site

    Berlin, 12045

  • Study site

    Berlin, 12099

  • Study site

    Berlin, 12247

  • Study site

    Bochum, 44789

  • Study site

    Bottrop, 46242

  • Study site

    Bovenden, 37120

  • Study site

    Braunschweig, 38118

  • Study site

    Bremen, 28277

  • Study site

    Coesfeld, 48653

  • Study site

    Cologne, 51109

  • Study site

    Darmstadt, 64295

  • Study site

    Darmstadt, 64925

  • Study site

    Daun, 54550

  • Study site

    Demmin, 17109

  • Study site

    Dessau, 06847

  • Study site

    Dortmund, 44263

  • Study site

    Düsseldorf, 40210

  • Study site

    Düsseldorf, 40225

  • Study site

    Düsseldorf, 40625

  • Study site

    Erfurt, 99089

  • Study site

    Essen, 45122

  • Study site

    Frankfurt am Main, 60596

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Freiburg im Breisgau, 97110

  • Study site

    Freudenstadt, 72250

  • Study site

    Fulda, 36043

  • Study site

    Fürstenzell, 94081

  • Study site

    Fürth, 90766

  • Study site

    Gelsenkirchen, 45886

  • Study site

    Gelsenkirchen, 45894

  • Study site

    Gerolstein, 54568

  • Study site

    Giessen, 35392

  • Study site

    Göttingen, 37075

  • Study site

    Greifswald, 17489

  • Study site

    Gütersloh, 33332

  • Study site

    Halle, 06120

  • Study site

    Hamburg, 20246

  • Study site

    Hamburg, 22297

  • Study site

    Hannoversch Münden, 34346

  • Study site

    Harsewinkel, 33428

  • Study site

    Heide, 25746

  • Study site

    Heidelberg, 69120

  • Study site

    Heilbronn, 74076

  • Study site

    Hildesheim, 31139

  • Study site

    Homburg, 66421

  • Study site

    Homburg/saar, 66424

  • Study site

    Idar-Oberstein, 55743

  • Study site

    Jena, 07751

  • Study site

    Karlsruhe, 76133

  • Study site

    Kiel, 24105

  • Study site

    Krefeld, 47798

  • Study site

    Lauterbach, 36341

  • Study site

    Leipzig, 04103

  • Study site

    Leipzig, 04129

  • Study site

    Lennestadt, 57368

  • Study site

    Lüdenscheid, 58515

  • Study site

    Ludwigsburg, 71640

  • Study site

    Ludwigshafen, 67063

  • Study site

    Marburg, 35043

  • Study site

    Marl, 45768

  • Study site

    Meiningen, 98617

  • Study site

    Memmingen, 87700

  • Study site

    Minden, 32425

  • Study site

    Mönchengladbach, 41236

  • Study site

    München, 81545

  • Study site

    Neuruppin, 16816

  • Study site

    Oberschleißheim, 85764

  • Study site

    Offenbach, 63069

  • Study site

    Offenburg, 77654

  • Study site

    Potsdam, 14482

  • Study site

    Recklinghausen, 45659

  • Study site

    Regensburg, 93053

  • Study site

    Reutlingen, 72764

  • Study site

    Ribnitz-Damgarten, 18311

  • Study site

    Rostock, 18057

  • Study site

    Rostock, 18107

  • Study site

    Saarbrücken, 6119

  • Study site

    Schloss Holte-stutenbrock, 38758

  • Study site

    Schwerin, 19049

  • Study site

    Schwerin, 19057

  • Study site

    Schwetzingen, 68723

  • Study site

    Stralsund, 18435

  • Study site

    Stuttgart, 70199

  • Study site

    Stuttgart, 70376

  • Study site

    Trier, 54292

  • Study site

    Waiblingen, 71334

  • Study site

    Weinheim, 69469

  • Study site

    Weinheim, 79539

  • Study site

    Wiesbaden, 65191

  • Study site

    Wiesloch, 69168

  • Study site

    Wuppertal, 42103

  • Study site

    Wuppertal, 42283

  • Study site

    Würzburg, 97072

Other trials in Germany

About this study

Official title: An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.

This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 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

    iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa

Study groups in NCT00413894
Study groupRoleWhat they receive
1ExperimentalNot 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.

  1. Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase

    Measured: Visits 8 to 10 (Months 6 to 8)

  2. Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase

    Measured: Visits 8 to 10 (Months 6 to 8)

  3. Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase

    Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

    Measured: Visits 8 to 10 (Months 6 to 8)

  4. Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase

    Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

    Measured: Visits 8 to 10 (Months 6 to 8)

Secondary outcomes (8)

  1. Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase

    Measured: Visits 1 to 2 (Months -2 to -1)

  2. Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase

    Measured: Visits 1 to 2 (Months -2 to -1)

  3. Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase

    Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

    Measured: Visits 1 to 2 (Months -2 to -1)

  4. Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase

    Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

    Measured: Visits 1 to 2 (Months -2 to -1)

  5. Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels

    Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.

    Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted.

    Measured: Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)

  6. Percentage of Participants With Hb Fluctuations Within Evaluation Phase

    Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.

    Measured: Visits 8 to 10 (Months 6 to 8)

  7. Percentage of Participants With Hb Fluctuations Within Screening Phase

    Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.

    Measured: Visits 1 to 2 (Months -2 to -1)

  8. Percentage of Participants Requiring Erythrocyte Transfusions

    Measured: Visits 1 to 10 (Months -2 to 8)

Timeline

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

  1. First posted20 Dec 2006 (estimated)
  2. Study startMar 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

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
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00413894
Sponsor's protocol ID
ML20572
Status last verified
Jan 2016
First submitted
19 Dec 2006
Last updated
15 Feb 2016

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

  • Fliser D, Kleophas W, Dellanna F, Winkler RE, Backs W, Kraatz U, Fassbinder W, Wizemann V, Strack G. Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study. Curr Med Res Opin. 2010 May;26(5):1083-9. doi: 10.1185/03007991003666652.

    PubMed 20225992

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 105 sites in Germany.

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 5 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in Germany. 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 15 Feb 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 With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase (time frame: Visits 8 to 10 (Months 6 to 8)). The study lists 4 primary outcomes in all. 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 NCT00413894, which also lists 2 linked publications.

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 15 Feb 2016.

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