A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

324

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
      • Liverpool, Australia, 1871
      • Parkville, Australia, 3052
      • Perth, Australia, 6847
  • Belgium
      • Antwerpen, Belgium, 2060
      • Leuven, Belgium, 3000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Kamloops, British Columbia, Canada, V2C 2T1
      • New Westminster, British Columbia, Canada, V3L 3W7
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1N9
      • London, Ontario, Canada, N6A 5A5
      • Scarborough, Ontario, Canada, M1H 3G4
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 2C4
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3A 1A1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1N4
  • France
      • Angers, France, 49933
      • Besancon, France, 25030
      • Chartres, France, 28000
      • Colmar, France, 68024
      • Lille, France, 59037
      • Lyon, France, 69437
      • Nantes, France, 44035
      • Paris, France, 75743
      • Paris, France, 75908
      • Perpignan, France, 66046
      • Salouel, France, 80480
      • Toulouse, France, 31059
      • Vandoeuvre-les-nancy, France, 54511
  • Germany
      • Aschaffenburg, Germany, 63741
      • Berlin, Germany, 13353
      • Bonn, Germany, 53127
      • Dortmund, Germany, 44263
      • Düsseldorf, Germany, 40225
      • Tübingen, Germany, 72076
  • Greece
      • Alexandroupolis, Greece, 68100
      • Athens, Greece, 11527
      • Ioannina, Greece, 455 00
      • Piraeus, Greece, 18536
      • Thessaloniki, Greece, 54629
  • Italy
      • Cagliari, Italy, 91034
      • Cuneo, Italy, 12100
      • Genova, Italy, 16132
      • Lecco, Italy, 23900
      • Lodi, Italy, 26900
      • Modena, Italy, 41100
      • Napoli, Italy, 80131
      • Padova, Italy, 35128
      • Pavia, Italy, 27100
      • Prato, Italy, 50047
      • Reggio Calabria, Italy, 89124
      • Roma, Italy, 00184
  • Netherlands
      • Amersfoort, Netherlands, 3818
      • Heerlen, Netherlands, 6419 PC
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
  • Spain
      • Almería, Spain, 04009
      • Barcelona, Spain, 08907
      • Lerida, Spain, 25198
      • Madrid, Spain, 28046
      • Madrid, Spain, 28041
      • Madrid, Spain, 28805
      • Palma de Mallorca, Spain, 07014
      • Valencia, Spain, 46017
  • Sweden
      • Boras, Sweden, 50142
      • Umea, Sweden, 90185
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
      • Carshalton, United Kingdom, SM5 1AA
      • Leicester, United Kingdom, LE5 4PW
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, SE22 8PT
      • London, United Kingdom, SW17 0RE
  • United States
    • California
      • Los Angeles, California, United States, 90073
      • Mather, California, United States, 95655
      • Stanford, California, United States, 94305-5114
    • Connecticut
      • Stamford, Connecticut, United States, 06902
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Ocala, Florida, United States, 34471
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Detroit, Michigan, United States, 48236
    • New York
      • Flushing, New York, United States, 11355
    • Ohio
      • Cincinnati, Ohio, United States, 45220
    • Oregon
      • Portland, Oregon, United States, 97201-2940
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
    • South Carolina
      • Columbia, South Carolina, United States, 29209
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75216
      • Houston, Texas, United States, 77054
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • 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:

  • adult patients >=18 years of age;
  • chronic kidney disease;
  • anemia;
  • not on dialysis therapy;
  • not receiving epoetin.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of another investigational drug within 4 weeks before screening, or during the study period.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg sc (starting dose) once every 2 weeks
Active Comparator: 2
Drug: darbepoetin alfa
0.45 micrograms/kg sc (starting dose) weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin response rate
Time Frame: Weeks 1-28
Weeks 1-28

Secondary Outcome Measures

Outcome Measure
Time Frame
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n
Time Frame: Throughout study
Throughout study

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

June 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

April 13, 2004

First Submitted That Met QC Criteria

April 15, 2004

First Posted (Estimate)

April 16, 2004

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA16738

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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