Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects 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:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01737879
First received: October 3, 2012
Last updated: March 26, 2013
Last verified: March 2013
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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. This is a multicenter, single-arm, open-label study in which hemodialysis subjects treated with epoetin alfa will first be converted to peginesatide, and then converted back to epoetin alfa. The primary endpoint is the mean hemoglobin during the evaluation period.
| 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 during evaluation period [ Time Frame: Last 8 weeks of epoetin alfa period ] [ Designated as safety issue: No ]To evaluate whether subjects receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin
Secondary Outcome Measures:
- Mean dose of Epoetin alfa during the evaluation period [ Time Frame: Last 8 weeks of Epoetin alfa treatment period ] [ Designated as safety issue: No ]To describe hemoglobin-related parameters in hemodialysis subjects converted from peginesatide to Epoetin alfa
- Hemoglobin every 2 weeks [ Time Frame: Every 2 weeks during peginesatide and Epoetin alfa periods ] [ Designated as safety issue: No ]To describe hemoglobin-related parameters in hemodialysis subjects converted from peginesatide to Epoetin alfa
- Dose every 2 weeks [ Time Frame: Every 2 weeks during peginesatide and Epoetin alfa periods ] [ Designated as safety issue: No ]To describe hemoglobin-related parameters in hemodialyis subjects converted from peginesatide to Epoetin alfa
| Enrollment: | 41 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: All Subjects |
Drug: Peginesatide
All subjects will receive peginesatide for the first 24 weeks.
Other Name: Omontys
Drug: Epoetin alfa
All subjects 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 subjects 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 subjects treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these subjects 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
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 |
| Last Updated: | March 26, 2013 |
| 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 May 19, 2013