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

This study has been terminated.
(Terminated: Test article, Omontys, was recalled from the market; Enrollment has halted prematurely and will not resume; participants are no longer being treated)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01737879
First received: October 3, 2012
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: Peginesatide
Drug: Epoetin alfa
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Mean Hemoglobin Concentration During the Evaluation Period [ Time Frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56). ] [ Designated as safety issue: No ]

    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 [ Time Frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56). ] [ Designated as safety issue: No ]
    No participant reached the evaluation period, therefore, this endpoint could not be evaluated.

  • Hemoglobin Concentration by Visit [ Time Frame: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21 ] [ Designated as safety issue: No ]
  • Peginesatide Dose by Visit [ Time Frame: Baseline and Weeks 5, 9, 13, and 17 ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Omontys
Drug: Epoetin alfa
All participants converted to epoetin alfa at week 25 for a total of 32 weeks
Other Name: Epogen

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737879

Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85004
Research Site
Tempe, Arizona, United States, 85284
United States, California
Research Site
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
United States, Connecticut
Research Site
Orange, Connecticut, United States, 06477
United States, Idaho
Research Site
Meridian, Idaho, United States, 83642
United States, Missouri
Research Site
Kansas City, Missouri, United States, 64111
United States, New Jersey
Research Site
Bayonne, New Jersey, United States, 07002
United States, New York
Research Site
Amherst, New York, United States, 14221
Research Site
Yonkers, New York, United States, 10704
United States, North Carolina
Research Site
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73116
United States, South Carolina
Research Site
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Research Site
Dyersburg, Tennessee, United States, 38024
Research Site
Jackson, Tennessee, United States, 38305
United States, Texas
Research Site
Houston, Texas, United States, 77004
United States, Virginia
Research Site
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01737879     History of Changes
Other Study ID Numbers: 20110209
Study First Received: October 3, 2012
Results First Received: March 14, 2014
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Amgen:
Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014