Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis
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| ClinicalTrials.gov Identifier: NCT01737879 |
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Recruitment Status :
Terminated
(Terminated: Test article, Omontys, was recalled from the market; Enrollment has halted prematurely and will not resume; participants are no longer being treated)
First Posted : November 30, 2012
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anemia | Drug: Peginesatide Drug: Epoetin alfa | Phase 4 |
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 (Clinical Trial) |
| Actual Enrollment : | 41 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | March 2013 |
| Actual Study Completion Date : | July 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Epoetin Alfa
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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). ]
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). ]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 ]
- Peginesatide Dose by Visit [ Time Frame: Baseline and Weeks 5, 9, 13, and 17 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01737879 |
| Other Study ID Numbers: |
20110209 |
| First Posted: | November 30, 2012 Key Record Dates |
| Results First Posted: | April 21, 2014 |
| Last Update Posted: | April 21, 2014 |
| Last Verified: | March 2014 |
Keywords provided by Amgen:
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Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin |
Additional relevant MeSH terms:
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Anemia Hematologic Diseases Epoetin Alfa Hematinics |