A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

November 9, 2011 updated by: Hoffmann-La Roche

A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.

This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Rainbow City, Alabama, United States
    • Arizona
      • Hot Springs, Arizona, United States
    • California
      • Fairfield, California, United States
      • Los Alamitos, California, United States
      • Los Angeles, California, United States
      • Mountain View, California, United States
      • Riverside, California, United States
      • San Diego, California, United States
      • Simi Valley, California, United States
      • Whittier, California, United States
    • Colorado
      • Lakewood, Colorado, United States
    • Florida
      • Brandon, Florida, United States
      • Hudson, Florida, United States
      • Lauderdale Lakes, Florida, United States
      • Miami, Florida, United States
      • Ocala, Florida, United States
      • Palm Beach Gardens, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Illinois
      • Gurnee, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
    • Michigan
      • Detroit, Michigan, United States
      • Pontiac, Michigan, United States
    • Nevada
      • Sparks, Nevada, United States
    • New Jersey
      • New Brunswick, New Jersey, United States
    • New York
      • Bronx, New York, United States
      • Brooklyn, New York, United States
      • Brooklyn Center, New York, United States
      • Flushing, New York, United States
      • Orchard Park, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Toledo, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States
      • Lewistown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • West Homestead, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Orangeburg, South Carolina, United States
    • Texas
      • Corpus Christi, Texas, United States
      • Houston, Texas, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Fairfax, Virginia, United States

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;
  • CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;
  • CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;
  • average hemoglobin (Hb) 10-12 g/dL over last 3 months.

Exclusion Criteria:

  • failed renal transplant within 12 months prior to screening;
  • poorly controlled hypertension;
  • previous treatment with Mircera.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: methoxy polyethylene glycol-epoetin beta
120-360 micrograms (iv) monthly, starting dose
Drug: methoxy polyethylene glycol-epoetin beta
120-360 micrograms intravenous (iv) monthly, starting dose
Other Names:
  • Mircera
ACTIVE_COMPARATOR: Epoetin Alfa
As prescribed, (iv), 3 times weekly
Drug: Epoetin alfa
As prescribed, iv, 3 times weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Spent on Anemia Treatment Over Evaluation Period
Time Frame: Months 5-7
Efficacy and pharmacoeconomics analyses were not performed.
Months 5-7
Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period
Time Frame: Baseline, Months 5-7
Efficacy and pharmacoeconomics analyses were not performed.
Baseline, Months 5-7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Assessed for AEs
Time Frame: Month 1 to 15 day follow up post month 7
The adverse events are captured in the adverse event and serious adverse event section of this database.
Month 1 to 15 day follow up post month 7
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Time Frame: Baseline, Month 1 to Month 7
A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.
Baseline, Month 1 to Month 7

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

March 1, 2007

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

January 15, 2007

First Submitted That Met QC Criteria

January 15, 2007

First Posted (ESTIMATE)

January 17, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 14, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20336

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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