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Terminated: Test article, Omontys, was recalled from the market; Enrollment has halted prematurely and will not resume; participants are no longer being treated
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginesatide / Epoetin Alfa | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginesatide | Drug | All participants will receive peginesatide for the first 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Dose of Epoetin Alfa During the Evaluation Period | No participant reached the evaluation period, therefore, this endpoint could not be evaluated. | Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56). |
| Hemoglobin Concentration by Visit |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85004 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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First patient was enrolled on 24 October 2012; Last patient was enrolled on 21 February 2013. The study was terminated on 27 March 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginesatide | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Epoetin alfa | Drug | All participants converted to epoetin alfa at week 25 for a total of 32 weeks |
|
|
| Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21 |
| Peginesatide Dose by Visit | Baseline and Weeks 5, 9, 13, and 17 |
| 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 |
| Received Peginesatide |
|
| Transitioned to Epoetin Alfa |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginesatide | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56). |
|
| ||||||||||||||||||||
| Secondary | Mean Dose of Epoetin Alfa During the Evaluation Period | No participant reached the evaluation period, therefore, this endpoint could not be evaluated. | Posted | Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56). |
|
| ||||||||||||||||||||
| Secondary | Hemoglobin Concentration by Visit | Primary analysis set includes all enrolled participants who received at least 1 dose of investigational product. The number of participants with available data at each time point is indicated by "n". | Posted | Mean | Standard Deviation | g/dL | Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21 |
|
| |||||||||||||||||
| Secondary | Peginesatide Dose by Visit | Primary analysis set, with available data at each time point (indicated by n) | Posted | Mean | Standard Deviation | mg | Baseline and Weeks 5, 9, 13, and 17 |
|
|
From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peginesatide | 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. | 3 | 34 | 6 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular asystole | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C556270 | peginesatide |
| C514771 | hematide |
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Other |
|
|
| Title | Denominators | Categories |
|---|
| Baseline (n=30) |
| |||||
| Week 5 (n=16) |
| |||||
| Week 9 (n=15) |
| |||||
| Week 13 (n=9) |
| |||||
| Week 17 (n=9) |
|