A Study of Intravenous or Subcutaneous 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 Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 7W9
      • Toronto, Ontario, Canada, M5G 2C4
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Montreal, Quebec, Canada, H3G 1A4
  • France
      • Aix En Provence, France, 13616
      • Chambery, France, 73011
      • Hyeres, France, 83400
      • Le Kremlin-bicetre, France, 94275
      • Nantes, France, 44093
      • Paris, France, 75970
      • Rouen, France, 76031
  • Germany
      • Erlangen, Germany, 91054
      • München, Germany, 80804
      • Nürnberg, Germany, 90431
  • Italy
      • Como, Italy, 22100
      • Modena, Italy, 41100
      • Pavia, Italy, 27100
  • Poland
      • Rzeszow, Poland, 35-055
      • Warszawa, Poland, 02-006
  • Portugal
      • Carnaxide, Portugal, 2799-523
      • Porto, Portugal, 4099-001
      • Setubal, Portugal, 2910-446
  • Puerto Rico
      • Ponce, Puerto Rico, 00732
      • San Juan, Puerto Rico, 00936-5067
  • Spain
      • Alicante, Spain, 03010
      • Madrid, Spain, 28007
  • Taiwan
      • Kaohsiung, Taiwan, 833
      • Taichung, Taiwan, 407
      • Taipei, Taiwan, 100
  • Thailand
      • Bangkok, Thailand
  • United Kingdom
      • Glasgow, United Kingdom, G4 OSF
      • Hertford, United Kingdom, SG1 4AB
      • London, United Kingdom, E1 1BB
      • Salford, United Kingdom, M6 8HD
      • Swansea, United Kingdom, SA6 6NL
  • United States
    • California
      • Covina, California, United States, 91723
      • Los Alamitos, California, United States, 90720
      • Los Angeles, California, United States, 90073
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92161
    • Florida
      • Tampa, Florida, United States, 33617
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Illinois
      • South Holland, Illinois, United States, 60473
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70884
      • Shreveport, Louisiana, United States, 71101
      • Shreveport, Louisiana, United States, 71103
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
    • Mississippi
      • Columbus, Mississippi, United States, 39705
      • Tupelo, Mississippi, United States, 38801
    • Missouri
      • St. Louis, Missouri, United States, 63128
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • Flushing, New York, United States, 11355
      • New York, New York, United States, 10025
      • Orchard Park, New York, United States, 14127
    • Ohio
      • Cleveland, Ohio, United States, 44109
      • Cleveland, Ohio, United States, 44195
    • Oregon
      • Oregon City, Oregon, United States, 97045
    • Pennsylvania
      • 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
    • South Carolina
      • Columbia, South Carolina, United States, 29209
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • 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;
  • on dialysis therapy for at least 12 weeks before screening;
  • receiving iv or sc epoetin for at least 8 weeks before screening.

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]
30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks
Active Comparator: 2
Drug: epoetin alfa or beta
iv or sc, as prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in hemoglobin concentration
Time Frame: Weeks 1-36
Weeks 1-36

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs, laboratory parameters, vital signs
Time Frame: Throughout study
Throughout study
Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration
Time Frame: Weeks 29-36
Weeks 29-36
RBC transfusions
Time Frame: Weeks 1-36
Weeks 1-36

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)

March 1, 2006

Study Completion (Actual)

March 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

  • BA17284

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.

Clinical Trials on Anemia

Clinical Trials on methoxy polyethylene glycol-epoetin beta [Mircera]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe