A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090753
Recruitment Status : Completed
First Posted : September 6, 2004
Results First Posted : January 5, 2012
Last Update Posted : February 14, 2012
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.

Condition or disease Intervention/treatment Phase
Anemia Drug: Methoxy Polyethylene Glycol-Epoetin Beta Drug: Epoetin alfa Drug: Epoetin beta Drug: Darbepoetin alfa Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1228 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
Study Start Date : October 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: Methoxy Polyethylene Glycol-Epoetin Beta
Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.
Other Names:
  • RO0503821
  • Mircera
Active Comparator: Comparator ESA
Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
Drug: Epoetin alfa
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
Drug: Epoetin beta
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
Drug: Darbepoetin alfa
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).

Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation [ Time Frame: Baseline to the end of the study (Up to 49 Months) ]
    Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.

Secondary Outcome Measures :
  1. Percentage of Patients Who Had at Least 1 Adverse Event [ Time Frame: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) ]
    See the adverse events section of the results for more information.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Adult patients (≥ 18 years old) with chronic renal anemia
  • Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484]
  • Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
  • Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) < 10%

Exclusion Criteria:

  • Poorly controlled hypertension
  • History of epileptic seizure
  • Pure red cell aplasia
  • Chronic congestive heart failure [New York Heart Association (NYHA) IV]
  • High likelihood of early withdrawal or interruption of the study
  • Active malignant disease (except non-melanoma skin cancer)
  • Life expectancy less than 12 months
  • Pregnancy or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090753

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United States, Alabama
Birmingham, Alabama, United States, 35211
Mobile, Alabama, United States, 36608
Montgomery, Alabama, United States, 36106
United States, Arkansas
Hot Springs, Arkansas, United States, 71901
United States, California
Covina, California, United States, 91723
Encino, California, United States, 91356
Irvine, California, United States, 92868
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Colorado Springs, Colorado, United States, 80909
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Stamford, Connecticut, United States, 06902
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Ocala, Florida, United States, 34471
Pembroke Pines, Florida, United States, 33028
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Atlanta, Georgia, United States, 30342
Augusta, Georgia, United States, 30309
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Honolulu, Hawaii, United States, 96813
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Maywood, Illinois, United States, 60153
South Holland, Illinois, United States, 60473
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Louisville, Kentucky, United States, 40202-1718
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Baton Rouge, Louisiana, United States, 70884
Shreveport, Louisiana, United States, 71101
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Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02135
Springfield, Massachusetts, United States, 01107
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Detroit, Michigan, United States, 48202-2689
Detroit, Michigan, United States, 48236
Kalamazoo, Michigan, United States, 49007
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Brooklyn Center, Minnesota, United States, 55430
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Columbus, Mississippi, United States, 39705
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St Louis, Missouri, United States, 63110
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Hackensack, New Jersey, United States, 07601
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Albuquerque, New Mexico, United States, 87131
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Bronx, New York, United States, 10467
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Chapel Hill, North Carolina, United States, 27599-7155
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Cincinnati, Ohio, United States, 45267-0585
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Oregon City, Oregon, United States, 97045
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Portland, Oregon, United States, 97210
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Allentown, Pennsylvania, United States, 18103
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Lewistown, Pennsylvania, United States, 17044
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Philadelphia, Pennsylvania, United States, 19140
Philadelphia, Pennsylvania, United States, 19141
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Columbia, South Carolina, United States, 29209
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Chattanooga, Tennessee, United States, 37404
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Nashville, Tennessee, United States, 37232
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Austin, Texas, United States, 78758
Dallas, Texas, United States, 75216
Houston, Texas, United States, 77030
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Houston, Texas, United States, 77099
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Burlington, Vermont, United States, 05401
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Fairfax, Virginia, United States, 22031
Norfolk, Virginia, United States, 23507-1901
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Morgantown, West Virginia, United States, 26506
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Liverpool, Australia, 1871
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Perth, Australia, 6847
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Aalst, Belgium, 9300
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Odense, Denmark, 5000
Roskilde, Denmark, 4000
HUS, Finland, 00029
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Bayonne, France, 64115
Bois Guillaume, France, 76233
Bordeaux, France, 33076
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Bad Hersfeld, Germany, 36251
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Debrecen, Hungary, 4032
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Bergamo, Italy, 24128
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Cremona, Italy, 26100
Cuneo, Italy, 12100
Genova, Italy, 16132
Lecco, Italy, 23900
Livorno, Italy, 57100
Lodi, Italy, 26900
Messina, Italy, 98158
Mestre, Italy, 30174
Modena, Italy, 41100
Pavia, Italy, 27100
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S Fermo Della Battaglia, Italy, 22020
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Kielce, Poland, 25-736
Krakow, Poland, 31-501
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Warszawa, Poland, 02-006
Wolomin, Poland, 05-200
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Moscow, Russian Federation, 123182
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 129110
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Sevilla, Spain, 41013
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Stockholm, Sweden, 18288
Umea, Sweden, 90185
Aarau, Switzerland, 5001
Lausanne, Switzerland, 1003
Lausanne, Switzerland, 1011
Taichung, Taiwan, 407
Taipei, Taiwan, 100
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Bangkok, Thailand
Chiang Mai, Thailand, 50200
Chonburi, Thailand
Phitsanulok, Thailand, 65000
United Kingdom
Belfast, United Kingdom, BT9 7LJ
Cambridge, United Kingdom, CB2 2QQ
Carshalton, United Kingdom, SM5 1AA
Dundee, United Kingdom, DD1 9SY
Exeter, United Kingdom, EX2 5DW
Glasgow, United Kingdom, G4 OSF
Leicester, United Kingdom, LE5 4PW
London, United Kingdom, E1 1BB
London, United Kingdom, SE1 9RT
London, United Kingdom, SE22 8PT
London, United Kingdom, SW17 0RE
Salford, United Kingdom, M6 8HD
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00090753     History of Changes
Other Study ID Numbers: BH18387
First Posted: September 6, 2004    Key Record Dates
Results First Posted: January 5, 2012
Last Update Posted: February 14, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Hematologic Diseases
Epoetin Alfa
Darbepoetin alfa