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

February 10, 2012 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Clayton, Australia, 3186
      • Gosford, Australia, 2250
      • Liverpool, Australia, 1871
      • Parkville, Australia, 3050
      • Perth, Australia, 6847
      • Sydney, Australia, NSW 2148
      • Woolloongabba, Australia, 4102
  • Austria
      • Graz, Austria, 8036
  • Belgium
      • Aalst, Belgium, 9300
      • Bruxelles, Belgium, 1200
      • Edegem, Belgium, 2650
      • Gent, Belgium, 9000
      • Hasselt, Belgium, 3500
      • Leuven, Belgium, 3000
      • Liege, Belgium, 4000
  • Czech Republic
      • Liberec, Czech Republic, 460 63
      • Ostrava, Czech Republic, 708 52
      • Plzen, Czech Republic, 304 60
  • Denmark
      • Aalborg, Denmark, 9100
      • Odense, Denmark, 5000
      • Roskilde, Denmark, 4000
  • Finland
      • HUS, Finland, 00029
      • Tampere, Finland, 33521
  • France
      • Bayonne, France, 64115
      • Bois Guillaume, France, 76233
      • Bordeaux, France, 33076
      • Boulogne, France, 62321
      • Cabestany, France, 66330
      • Caen, France, 14033
      • Chambery, France, 73001
      • Colmar, France, 68024
      • Hyeres, France, 83400
      • La Tronche, France, 38700
      • Limoges, France, 87042
      • Lyon, France, 69437
      • Montpellier, France, 34295
      • Nantes, France, 44093
      • Nimes, France, 30029
      • Paris, France, 75908
      • Perpignan, France, 66046
      • Poitiers, France, 86021
      • Saint Ouen, France, 93400
      • Saint-germain-en-laye, France, 78100
      • Salouël, France, 80480
      • Tarbes, France, 65013
      • Thionville, France, 57126
      • Toulouse, France, 31059
      • Tours, France, 37044
  • Germany
      • Bad Hersfeld, Germany, 36251
      • Berlin, Germany, 12045
      • Dortmund, Germany, 44263
      • Erlangen, Germany, 91054
      • München, Germany, 80804
      • Nürnberg, Germany, 90431
      • Stuttgart, Germany, 70191
      • Villingen-schwenningen, Germany, 78054
      • Wiesbaden, Germany, 65191
      • Wiesloch, Germany, 69168
      • Wuppertal, Germany, 42103
  • Greece
      • Alexandroupolis, Greece, 68100
      • Ioannina, Greece, 45500
      • Larissa, Greece, 41110
      • Piraeus, Greece, 18536
      • Thessaloniki, Greece, 54629
  • Hungary
      • Budapest, Hungary, 1134
      • Budapest, Hungary, 1076
      • Debrecen, Hungary, 4032
      • Miskolc, Hungary, 3526
      • Pecs, Hungary, 7624
  • Italy
      • Bergamo, Italy, 24128
      • Cagliari, Italy, 91034
      • 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
      • Prato, Italy, 50047
      • Reggio Calabria, Italy, 89100
      • S Fermo Della Battaglia, Italy, 22020
      • Venezia, Italy, 30122
  • Mexico
      • Cuernavaca, Mexico, 62448
      • Mexico City, Mexico, 14000
  • Netherlands
      • Heerlen, Netherlands, 6419 PC
  • Norway
      • Trondheim, Norway, 7006
  • Panama
      • Panama City, Panama
  • Poland
      • Gdansk, Poland, 80-211
      • Gdynia, Poland, 81-519
      • Kielce, Poland, 25-736
      • Krakow, Poland, 31-501
      • Lodz, Poland, 90-153
      • Poznan, Poland, 60-355
      • Rzeszow, Poland, 35-055
      • Szczecin, Poland, 70-111
      • Warszawa, Poland, 02-006
      • Wolomin, Poland, 05-200
      • Wroclaw, Poland, 50-417
  • Portugal
      • Setubal, Portugal, 2910-446
  • Puerto Rico
      • Ponce, Puerto Rico, 00732
  • Russian Federation
      • Moscow, Russian Federation, 123182
      • Moscow, Russian Federation, 125101
      • Moscow, Russian Federation, 129110
      • St Petersburg, Russian Federation, 195067
      • St Petersburg, Russian Federation, 197089
  • South Africa
      • Cape Town, South Africa, 7925
      • Durban, South Africa
      • Soweto, South Africa
  • Spain
      • Alcorcon, Spain, 28922
      • Alicante, Spain, 03010
      • Almería, Spain, 04009
      • Badalona, Spain, 08915
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Bilbao, Spain, 48013
      • Córdoba, Spain, 14004
      • Hospitalet de Llobregat, Spain, 08907
      • La Coruna, Spain, 15006
      • Lerida, Spain, 25198
      • Madrid, Spain, 28006
      • Madrid, Spain, 28046
      • Madrid, Spain, 28041
      • Madrid, Spain, 28805
      • Madrid, Spain, 28007
      • Madrid, Spain, 28222
      • Malaga, Spain, 29010
      • Oviedo, Spain, 33006
      • Palma de Mallorca, Spain, 07014
      • Palma de Mallorca, Spain, 07198
      • Salamanca, Spain, 37008
      • Santander, Spain, 39008
      • Santiago de Compostela, Spain, 15706
      • Sevilla, Spain, 41013
  • Sweden
      • Huddinge, Sweden, 14186
      • Karlstad, Sweden, 65185
      • Stockholm, Sweden, 18288
      • Umea, Sweden, 90185
  • Switzerland
      • Aarau, Switzerland, 5001
      • Lausanne, Switzerland, 1011
      • Lausanne, Switzerland, 1003
  • Taiwan
      • Taichung, Taiwan, 407
      • Taipei, Taiwan, 100
  • Thailand
      • Bangkok, Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Bangkok, Thailand, 10330
      • 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, SE1 9RT
      • London, United Kingdom, SE22 8PT
      • London, United Kingdom, SW17 0RE
      • London, United Kingdom, E1 1BB
      • Salford, United Kingdom, M6 8HD
      • Swansea, United Kingdom, SA6 6NL
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
      • Mobile, Alabama, United States, 36608
      • Montgomery, Alabama, United States, 36106
    • Arkansas
      • Hot Springs, Arkansas, United States, 71901
    • California
      • Covina, California, United States, 91723
      • Encino, California, United States, 91356
      • Irvine, California, United States, 92868
      • Los Alamitos, California, United States, 90720
      • Los Angeles, California, United States, 90073
      • Los Angeles, California, United States, 90095
      • Monterey Park, California, United States, 91754
      • Mountain View, California, United States, 94040
      • Sacramento, California, United States, 95816-5119
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92120
      • San Francisco, California, United States, 94117
      • Stanford, California, United States, 94305
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
      • Denver, Colorado, United States, 80262
      • Lakewood, Colorado, United States, 80260
    • Connecticut
      • Stamford, Connecticut, United States, 06902
    • Florida
      • Ocala, Florida, United States, 34471
      • Pembroke Pines, Florida, United States, 33028
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Augusta, Georgia, United States, 30309
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Illinois
      • Maywood, Illinois, United States, 60153
      • South Holland, Illinois, United States, 60473
    • Kentucky
      • Louisville, Kentucky, United States, 40202-1718
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70884
      • Shreveport, Louisiana, United States, 71101
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
      • Boston, Massachusetts, United States, 02115
      • Springfield, Massachusetts, United States, 01107
    • Michigan
      • Detroit, Michigan, United States, 48236
      • Detroit, Michigan, United States, 48202-2689
      • Kalamazoo, Michigan, United States, 49007
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
    • Mississippi
      • Columbus, Mississippi, United States, 39705
      • Tupelo, Mississippi, United States, 38801
    • Missouri
      • St Louis, Missouri, United States, 63110
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
      • Paterson, New Jersey, United States, 07503
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Bronx, New York, United States, 10467
      • Brooklyn, New York, United States, 11203
      • Flushing, New York, United States, 11355
      • Great Neck, New York, United States, 11021
      • Mineola, New York, United States, 11501
      • New York, New York, United States, 10021
      • New York, New York, United States, 10128
      • Orchard Park, New York, United States, 14127
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7155
      • Mount Airy, North Carolina, United States, 27030
      • Raleigh, North Carolina, United States, 27609
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0585
      • Cleveland, Ohio, United States, 44109
      • Toledo, Ohio, United States, 43606
    • Oregon
      • Oregon City, Oregon, United States, 97045
      • Portland, Oregon, United States, 97201-2940
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Erie, Pennsylvania, United States, 16502
      • Lewistown, Pennsylvania, United States, 17044
      • Philadelphia, Pennsylvania, United States, 19141
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19106
      • Pittsburgh, Pennsylvania, United States, 15224
    • South Carolina
      • Columbia, South Carolina, United States, 29209
      • Orangeburg, South Carolina, United States, 29118
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Nashville, Tennessee, United States, 37232
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Austin, Texas, United States, 78758
      • Dallas, Texas, United States, 75216
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77054
      • Houston, Texas, United States, 77099
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Fairfax, Virginia, United States, 22031
      • Norfolk, Virginia, United States, 23507-1901
      • Salem, Virginia, United States, 24153
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • Mircera
  • RO0503821
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to the end of the study (Up to 49 Months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

September 3, 2004

First Submitted That Met QC Criteria

September 3, 2004

First Posted (ESTIMATE)

September 6, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 10, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH18387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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