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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Study Type: Interventional
• Enrollment (Actual): 424
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
  • Aachen, Germany, 52066
  • Alzey, Germany, 55232
  • Ansbach, Germany, 91522
  • Augsburg, Germany, 86157
  • Bad König, Germany, 64732
  • Bad Neundorf, Germany, 31542
  • Bad Oeynhausen, Germany, 32545
  • Bad Orb, Germany, 63619
  • Bayreuth, Germany, 95445
  • Berlin, Germany, 10117
  • Berlin, Germany, 10249
  • Berlin, Germany, 12247
  • Berlin, Germany, 12099
  • Berlin, Germany, 12045
  • Bochum, Germany, 44789
  • Bottrop, Germany, 46242
  • Bovenden, Germany, 37120
  • Braunschweig, Germany, 38118
  • Bremen, Germany, 28277
  • Coesfeld, Germany, 48653
  • Darmstadt, Germany, 64295
  • Darmstadt, Germany, 64925
  • Daun, Germany, 54550
  • Demmin, Germany, 17109
  • Dessau, Germany, 06847
  • Dortmund, Germany, 44263
  • Düsseldorf, Germany, 40225
  • Düsseldorf, Germany, 40210
  • Düsseldorf, Germany, 40625
  • Erfurt, Germany, 99089
  • Essen, Germany, 45122
  • Frankfurt Am Main, Germany, 60596
  • Freiburg, Germany, 79106
  • Freiburg, Germany, 97110
  • Freudenstadt, Germany, 72250
  • Fulda, Germany, 36043
  • Fürstenzell, Germany, 94081
  • Fürth, Germany, 90766
  • Gelsenkirchen, Germany, 45886
  • Gelsenkirchen, Germany, 45894
  • Gerolstein, Germany, 54568
  • Giessen, Germany, 35392
  • Greifswald, Germany, 17489
  • Göttingen, Germany, 37075
  • Gütersloh, Germany, 33332
  • Halle, Germany, 06120
  • Hamburg, Germany, 20246
  • Hamburg, Germany, 22297
  • Hann. Münden, Germany, 34346
  • Harsewinkel, Germany, 33428
  • Heide, Germany, 25746
  • Heidelberg, Germany, 69120
  • Heilbronn, Germany, 74076
  • Hildesheim, Germany, 31139
  • Homburg, Germany, 66421
  • Homburg/saar, Germany, 66424
  • Idar-oberstein, Germany, 55743
  • Jena, Germany, 07751
  • Karlsruhe, Germany, 76133
  • Kiel, Germany, 24105
  • Krefeld, Germany, 47798
  • Köln, Germany, 51109
  • Lauterbach, Germany, 36341
  • Leipzig, Germany, 04103
  • Leipzig, Germany, 04129
  • Lennestadt, Germany, 57368
  • Ludwigsburg, Germany, 71640
  • Ludwigshafen, Germany, 67063
  • Lüdenscheid, Germany, 58515
  • Marburg, Germany, 35043
  • Marl, Germany, 45768
  • Meiningen, Germany, 98617
  • Memmingen, Germany, 87700
  • Minden, Germany, 32425
  • Mönchengladbach, Germany, 41236
  • München, Germany, 81545
  • Neuruppin, Germany, 16816
  • Oberschleissheim, Germany, 85764
  • Offenbach, Germany, 63069
  • Offenburg, Germany, 77654
  • Potsdam, Germany, 14482
  • Recklinghausen, Germany, 45659
  • Regensburg, Germany, 93053
  • Reutlingen, Germany, 72764
  • Ribnitz-damgarten, Germany, 18311
  • Rostock, Germany, 18057
  • Rostock, Germany, 18107
  • Saarbrücken, Germany, 6119
  • Schloss Holte-stutenbrock, Germany, 38758
  • Schwerin, Germany, 19049
  • Schwerin, Germany, 19057
  • Schwetzingen, Germany, 68723
  • Stralsund, Germany, 18435
  • Stuttgart, Germany, 70199
  • Stuttgart, Germany, 70376
  • Trier, Germany, 54292
  • Waiblingen, Germany, 71334
  • Weinheim, Germany, 69469
  • Weinheim, Germany, 79539
  • Wiesbaden, Germany, 65191
  • Wiesloch, Germany, 69168
  • Wuppertal, Germany, 42103
  • Wuppertal, Germany, 42283
  • Würzburg, Germany, 97072

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 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	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 1 to 2 (Months -2 to -1)
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.	Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)
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.	Visits 8 to 10 (Months 6 to 8)
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.	Visits 1 to 2 (Months -2 to -1)
Percentage of Participants Requiring Erythrocyte Transfusions		Visits 1 to 10 (Months -2 to 8)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General 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.
• 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. Erratum In: Curr Med Res Opin. 2010 Aug;26(8):1826. Dellana, F [corrected to Dellanna, F].

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: December 19, 2006
• First Submitted That Met QC Criteria: December 19, 2006
• First Posted (Estimate): December 20, 2006

Study Record Updates

• Last Update Posted (Estimate): February 15, 2016
• Last Update Submitted That Met QC Criteria: January 17, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML20572