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

Primary Purpose

Anemia

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Peginesatide
Epoetin alfa
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peginesatide / Epoetin Alfa

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean Hemoglobin Concentration During the Evaluation Period
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.

Secondary Outcome Measures

Mean Dose of Epoetin Alfa During the Evaluation Period
No participant reached the evaluation period, therefore, this endpoint could not be evaluated.
Hemoglobin Concentration by Visit
Peginesatide Dose by Visit

Full Information

First Posted
October 3, 2012
Last Updated
March 14, 2014
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01737879
Brief Title
Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis
Official Title
Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Terminated: Test article, Omontys, was recalled from the market; Enrollment has halted prematurely and will not resume; participants are no longer being treated
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peginesatide / Epoetin Alfa
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginesatide
Other Intervention Name(s)
Omontys
Intervention Description
All participants will receive peginesatide for the first 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Other Intervention Name(s)
Epogen
Intervention Description
All participants converted to epoetin alfa at week 25 for a total of 32 weeks
Primary Outcome Measure Information:
Title
Mean Hemoglobin Concentration During the Evaluation Period
Description
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.
Time Frame
Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Secondary Outcome Measure Information:
Title
Mean Dose of Epoetin Alfa During the Evaluation Period
Description
No participant reached the evaluation period, therefore, this endpoint could not be evaluated.
Time Frame
Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Title
Hemoglobin Concentration by Visit
Time Frame
Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21
Title
Peginesatide Dose by Visit
Time Frame
Baseline and Weeks 5, 9, 13, and 17

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Research Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Research Site
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Research Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Research Site
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Research Site
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
Research Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Research Site
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Research Site
City
Orange
State/Province
Connecticut
ZIP/Postal Code
06477
Country
United States
Facility Name
Research Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Research Site
City
Bayonne
State/Province
New Jersey
ZIP/Postal Code
07002
Country
United States
Facility Name
Research Site
City
Amherst
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Research Site
City
Yonkers
State/Province
New York
ZIP/Postal Code
10704
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Research Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Research Site
City
Dyersburg
State/Province
Tennessee
ZIP/Postal Code
38024
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Research Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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