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

NCT ID: NCT00413894

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type: DRUG

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

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Aachen, , Germany

Aachen, , Germany

Alzey, , Germany

Ansbach, , Germany

Augsburg, , Germany

Bad König, , Germany

Bad Nenndorf, , Germany

Bad Oeynhausen, , Germany

Bad Orb, , Germany

Bayreuth, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Bochum, , Germany

Bottrop, , Germany

Bovenden, , Germany

Braunschweig, , Germany

Bremen, , Germany

Coesfeld, , Germany

Cologne, , Germany

Darmstadt, , Germany

Darmstadt, , Germany

Daun, , Germany

Demmin, , Germany

Dessau, , Germany

Dortmund, , Germany

Düsseldorf, , Germany

Düsseldorf, , Germany

Düsseldorf, , Germany

Erfurt, , Germany

Essen, , Germany

Frankfurt am Main, , Germany

Freiburg im Breisgau, , Germany

Freiburg im Breisgau, , Germany

Freudenstadt, , Germany

Fulda, , Germany

Fürstenzell, , Germany

Fürth, , Germany

Gelsenkirchen, , Germany

Gelsenkirchen, , Germany

Gerolstein, , Germany

Giessen, , Germany

Göttingen, , Germany

Greifswald, , Germany

Gütersloh, , Germany

Halle, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hannoversch Münden, , Germany

Harsewinkel, , Germany

Heide, , Germany

Heidelberg, , Germany

Heilbronn, , Germany

Hildesheim, , Germany

Homburg, , Germany

Homburg/saar, , Germany

Idar-Oberstein, , Germany

Jena, , Germany

Karlsruhe, , Germany

Kiel, , Germany

Krefeld, , Germany

Lauterbach, , Germany

Leipzig, , Germany

Leipzig, , Germany

Lennestadt, , Germany

Ludwigsburg, , Germany

Ludwigshafen, , Germany

Lüdenscheid, , Germany

Marburg, , Germany

Marl, , Germany

Meiningen, , Germany

Memmingen, , Germany

Minden, , Germany

Mönchengladbach, , Germany

München, , Germany

Neuruppin, , Germany

Oberschleißheim, , Germany

Offenbach, , Germany

Offenburg, , Germany

Potsdam, , Germany

Recklinghausen, , Germany

Regensburg, , Germany

Reutlingen, , Germany

Ribnitz-Damgarten, , Germany

Rostock, , Germany

Rostock, , Germany

Saarbrücken, , Germany

Schloss Holte-stutenbrock, , Germany

Schwerin, , Germany

Schwerin, , Germany

Schwetzingen, , Germany

Stralsund, , Germany

Stuttgart, , Germany

Stuttgart, , Germany

Trier, , Germany

Waiblingen, , Germany

Weinheim, , Germany

Weinheim, , Germany

Wiesbaden, , Germany

Wiesloch, , Germany

Wuppertal, , Germany

Wuppertal, , Germany

Würzburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 26965694 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20225992 (View on PubMed)

Other Identifiers

ML20572

Identifier Type: -

Identifier Source: org_study_id