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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00413894
First received: December 19, 2006
Last updated: January 17, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels [ Time Frame: Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8) ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With Hb Fluctuations Within Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Hb Fluctuations Within Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Requiring Erythrocyte Transfusions [ Time Frame: Visits 1 to 10 (Months -2 to 8) ] [ Designated as safety issue: No ]

Enrollment: 424
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413894

  Hide Study Locations
Locations
Germany
Aachen, Germany, 52066
Aachen, Germany, 52074
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, 12045
Berlin, Germany, 12099
Berlin, Germany, 12247
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, 40625
Düsseldorf, Germany, 40225
Düsseldorf, Germany, 40210
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00413894     History of Changes
Other Study ID Numbers: ML20572 
Study First Received: December 19, 2006
Results First Received: January 17, 2016
Last Updated: January 17, 2016
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Darbepoetin alfa
Hematinics

ClinicalTrials.gov processed this record on May 25, 2016