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

NCT00413894 | Completed Phase 3 Results

• 1 other identifier: ML20572
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 105

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

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

  Visits 8 to 10 (Months 6 to 8)

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

  Visits 8 to 10 (Months 6 to 8)

• 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.

  Visits 8 to 10 (Months 6 to 8)

• 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.

  Visits 8 to 10 (Months 6 to 8)

Secondary Outcomes (8)

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

1

EXPERIMENTAL

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (105)

Unknown Facility

Aachen, 52066, Germany

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Aachen, 52074, Germany

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Alzey, 55232, Germany

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Ansbach, 91522, Germany

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Augsburg, 86157, Germany

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Bad König, 64732, Germany

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Bad Nenndorf, 31542, Germany

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Bad Oeynhausen, 32545, Germany

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Bad Orb, 63619, Germany

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Bayreuth, 95445, Germany

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Berlin, 10117, Germany

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Berlin, 10249, Germany

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Berlin, 12045, Germany

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Berlin, 12099, Germany

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Berlin, 12247, Germany

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Bochum, 44789, Germany

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Bottrop, 46242, Germany

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Bovenden, 37120, Germany

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Braunschweig, 38118, Germany

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Bremen, 28277, Germany

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Coesfeld, 48653, Germany

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Cologne, 51109, Germany

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Darmstadt, 64295, Germany

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Darmstadt, 64925, Germany

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Daun, 54550, Germany

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Demmin, 17109, Germany

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Dessau, 06847, Germany

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Dortmund, 44263, Germany

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Düsseldorf, 40210, Germany

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Düsseldorf, 40225, Germany

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Düsseldorf, 40625, Germany

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Erfurt, 99089, Germany

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Essen, 45122, Germany

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Frankfurt am Main, 60596, Germany

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Freiburg im Breisgau, 79106, Germany

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Freiburg im Breisgau, 97110, Germany

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Freudenstadt, 72250, Germany

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Fulda, 36043, Germany

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Fürstenzell, 94081, Germany

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Fürth, 90766, Germany

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Gelsenkirchen, 45886, Germany

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Gelsenkirchen, 45894, Germany

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Gerolstein, 54568, Germany

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Giessen, 35392, Germany

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Göttingen, 37075, Germany

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Greifswald, 17489, Germany

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Gütersloh, 33332, Germany

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Halle, 06120, Germany

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Hamburg, 20246, Germany

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Hamburg, 22297, Germany

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Hannoversch Münden, 34346, Germany

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Harsewinkel, 33428, Germany

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Heide, 25746, Germany

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Heidelberg, 69120, Germany

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Heilbronn, 74076, Germany

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Hildesheim, 31139, Germany

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Homburg, 66421, Germany

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Homburg/saar, 66424, Germany

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Idar-Oberstein, 55743, Germany

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Jena, 07751, Germany

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Karlsruhe, 76133, Germany

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Kiel, 24105, Germany

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Krefeld, 47798, Germany

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Lauterbach, 36341, Germany

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Leipzig, 04103, Germany

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Leipzig, 04129, Germany

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Lennestadt, 57368, Germany

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Ludwigsburg, 71640, Germany

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Ludwigshafen, 67063, Germany

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Lüdenscheid, 58515, Germany

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Marburg, 35043, Germany

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Marl, 45768, Germany

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Meiningen, 98617, Germany

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Memmingen, 87700, Germany

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Minden, 32425, Germany

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Mönchengladbach, 41236, Germany

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München, 81545, Germany

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Neuruppin, 16816, Germany

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Oberschleißheim, 85764, Germany

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Offenbach, 63069, Germany

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Offenburg, 77654, Germany

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Potsdam, 14482, Germany

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Recklinghausen, 45659, Germany

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Regensburg, 93053, Germany

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Reutlingen, 72764, Germany

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Ribnitz-Damgarten, 18311, Germany

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Rostock, 18057, Germany

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Rostock, 18107, Germany

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Saarbrücken, 6119, Germany

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Schloss Holte-stutenbrock, 38758, Germany

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Schwerin, 19049, Germany

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Schwerin, 19057, Germany

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Schwetzingen, 68723, Germany

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Stralsund, 18435, Germany

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Stuttgart, 70199, Germany

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Stuttgart, 70376, Germany

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Trier, 54292, Germany

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Waiblingen, 71334, Germany

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Weinheim, 69469, Germany

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Weinheim, 79539, Germany

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Wiesbaden, 65191, Germany

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Wiesloch, 69168, Germany

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Wuppertal, 42103, Germany

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Wuppertal, 42283, Germany

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Würzburg, 97072, Germany

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Related Publications (2)

• 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.

  PMID: 26965694 DERIVED

• 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.

  PMID: 20225992 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmannb-LaRoche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 20, 2006
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

DE (105)