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

November 1, 2016 updated by: Hoffmann-La Roche

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

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently 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)

182

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

  • Brazil
      • Curitiba, Brazil, 81050-090
      • Ribeirão Preto, Brazil, 14025-170
      • Sao Paulo, Brazil, 04039-000
      • Sao Paulo, Brazil, 01307-001
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
      • London, Ontario, Canada, N6A 5A5
      • Toronto, Ontario, Canada, M5G 2C4
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1N4
  • Czech Republic
      • Liberec, Czech Republic, 460 63
      • Praha, Czech Republic, 169 00
      • Usti Nad Labem, Czech Republic, 401 13
  • Greece
      • Alexandroupolis, Greece, 68100
      • Larissa, Greece, 41 110
      • Nikea, Greece, 18354
      • Thessaloniki, Greece, 54629
  • Norway
      • Bergen, Norway, 5021
      • Oslo, Norway, 0407
  • Poland
      • Gdansk, Poland, 80-211
      • Gdynia, Poland, 81-519
      • Krakow, Poland, 31-501
      • Lodz, Poland, 90-153
      • Poznan, Poland, 60-355
      • Szczecin, Poland, 70-111
      • Wolomin, Poland, 05-200
      • Wroclaw, Poland, 50-417
  • 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
      • Johannesburg, South Africa, 2193
      • Soweto, South Africa
  • Spain
      • Bilbao, Spain, 48013
      • Santander, Spain, 39008
  • Sweden
      • Karlstad, Sweden, 65185
  • Switzerland
      • Lausanne, Switzerland, 1011
  • Thailand
      • Bangkok, Thailand
      • Bangkok, Thailand, 10700
      • Chiang Mai, Thailand, 50200
      • Chonburi, Thailand
  • United States
    • California
      • Davis, California, United States, 95616
    • Colorado
      • Lakewood, Colorado, United States, 80260
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Augusta, Georgia, United States, 30901
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Springfield, Massachusetts, United States, 01107
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
    • New York
      • Mineola, New York, United States, 11501
      • New York, New York, United States, 10128
    • Ohio
      • Toledo, Ohio, United States, 43606
    • Texas
      • Houston, Texas, United States, 77054
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Norfolk, Virginia, United States, 23507-1901

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 renal anemia;
  • dialysis therapy for at least 2 weeks before screening.

Exclusion Criteria:

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

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]
0.4 micrograms/kg iv (starting dose) once every 2 weeks
Active Comparator: 2
Drug: epoetin
3 times a week iv, as prescribed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin response rate
Time Frame: Weeks 1-24
Weeks 1-24

Secondary Outcome Measures

Outcome Measure
Time Frame
Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

February 10, 2004

First Submitted That Met QC Criteria

February 11, 2004

First Posted (Estimate)

February 12, 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

  • BA16736

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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