Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis

March 14, 2014 updated by: Amgen

Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis

The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

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
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Research Site
      • Tempe, Arizona, United States, 85284
        • Research Site
    • California
      • Azusa, California, United States, 91702
        • Research Site
      • Bakersfield, California, United States, 93309
        • Research Site
      • Granada Hills, California, United States, 91344
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • Lynwood, California, United States, 90262
        • Research Site
      • Paramount, California, United States, 90723
        • Research Site
      • Riverside, California, United States, 92501
        • Research Site
      • Whittier, California, United States, 90603
        • Research Site
    • Connecticut
      • Orange, Connecticut, United States, 06477
        • Research Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
    • New Jersey
      • Bayonne, New Jersey, United States, 07002
        • Research Site
    • New York
      • Amherst, New York, United States, 14221
        • Research Site
      • Yonkers, New York, United States, 10704
        • Research Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Research Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Research Site
    • Tennessee
      • Dyersburg, Tennessee, United States, 38024
        • Research Site
      • Jackson, Tennessee, United States, 38305
        • Research Site
    • Texas
      • Houston, Texas, United States, 77004
        • Research Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Research Site

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

Key Inclusion Criteria:

  • Receiving hemodialysis 3 times a week
  • Receiving epoetin alfa IV 3 times a week
  • Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening

Key Exclusion Criteria:

  • Systemic hematologic disease
  • Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peginesatide / Epoetin Alfa
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
Drug: Peginesatide
All participants will receive peginesatide for the first 24 weeks.
Other Names:
  • Omontys
Drug: Epoetin alfa
All participants converted to epoetin alfa at week 25 for a total of 32 weeks
Other Names:
  • Epogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Hemoglobin Concentration During the Evaluation Period
Time Frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).

The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants.

No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.
Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Dose of Epoetin Alfa During the Evaluation Period
Time Frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
No participant reached the evaluation period, therefore, this endpoint could not be evaluated.
Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Hemoglobin Concentration by Visit
Time Frame: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21
Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21
Peginesatide Dose by Visit
Time Frame: Baseline and Weeks 5, 9, 13, and 17
Baseline and Weeks 5, 9, 13, and 17

Collaborators and Investigators

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

Sponsor

Amgen

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.

Helpful Links

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, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110209

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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