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

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia

Intervention: Peginesatide (Drug); Epoetin alfa (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean Hemoglobin Concentration During the Evaluation Period

Secondary outcome:

Mean Dose of Epoetin Alfa During the Evaluation Period

Hemoglobin Concentration by Visit

Peginesatide Dose by Visit

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Research Site, Phoenix, Arizona 85004, United States

Research Site, Tempe, Arizona 85284, United States

Research Site, Azusa, California 91702, United States

Research Site, Bakersfield, California 93309, United States

Research Site, Granada Hills, California 91344, United States

Research Site, Los Angeles, California 90057, United States

Research Site, Lynwood, California 90262, United States

Research Site, Paramount, California 90723, United States

Research Site, Riverside, California 92501, United States

Research Site, Whittier, California 90603, United States

Research Site, Orange, Connecticut 06477, United States

Research Site, Meridian, Idaho 83642, United States

Research Site, Kansas City, Missouri 64111, United States

Research Site, Bayonne, New Jersey 07002, United States

Research Site, Amherst, New York 14221, United States

Research Site, Yonkers, New York 10704, United States

Research Site, Winston-Salem, North Carolina 27103, United States

Research Site, Oklahoma City, Oklahoma 73116, United States

Research Site, Orangeburg, South Carolina 29118, United States

Research Site, Dyersburg, Tennessee 38024, United States

Research Site, Jackson, Tennessee 38305, United States

Research Site, Houston, Texas 77004, United States

Research Site, Chesapeake, Virginia 23320, United States

Additional Information

AmgenTrials clinical trials website

Starting date: October 2012
Last updated: March 14, 2014

Page last updated: August 23, 2015

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