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: July 7, 2014
Last verified: July 2014
  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 receiv ed treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receiv e 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: Allocation: Non-Randomized
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 patients in a defined Hb range and percentage of patients with or without dose adjustments, during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients in a defined Hb range, and percentage of patients with or without dose adjustments. [ Time Frame: During screening period ] [ Designated as safety issue: No ]
  • Incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]

Enrollment: 661
Study Start Date: February 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (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, 12099
Berlin, Germany, 10117
Berlin, Germany, 12045
Berlin, Germany, 10249
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, 97110
Freiburg, Germany, 79106
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, 22297
Hamburg, Germany, 20246
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, 04129
Leipzig, Germany, 04103
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

No publications provided by Hoffmann-La Roche

Additional 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
Last Updated: July 7, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Anemia
Renal Insufficiency, Chronic
Hematologic Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Darbepoetin alfa
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014