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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003459-64 | EudraCT Number | ||
| U1111-1114-1500 | Registry Identifier | WHO |
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| Name | Class |
|---|---|
| Affymax | INDUSTRY |
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The purpose of this study is to determine the efficacy and safety of Peginesatide Injection for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis or do not require dialysis and who were previously treated with Darbepoetin Alfa.
Anemia, resulting primarily from insufficient production of erythropoietin to support erythropoiesis, is a common consequence of chronic renal failure. Both North America and Europe have established clinical practice guidelines for the treatment and hemoglobin targets in chronic renal failure/chronic kidney disease patients. These guidelines recommend the use of erythropoiesis-stimulating agents (ESAs). The benefits of ESA therapy include reduced fatigue, improved quality of life, decreased cardiovascular mortality risk and improved cardiovascular function. An increased risk of death and serious cardiovascular and thromboembolic events, including myocardial infarction, stroke, congestive heart failure, and hemodialysis graft occlusion have been observed in controlled clinical trials of ESAs when administered to target hemoglobin levels of ≥13.5 g/dL. The vast majority of patients receiving hemodialysis receive ESA therapy to treat their anemia and most patients begin ESA therapy prior to any requirement for dialysis.
Anemia of chronic renal failure is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors also include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anemia increases with progressive deterioration of renal function, and affects more than 90% of patients with chronic renal failure Stage 5 (End Stage Renal Disease). Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, increased left ventricular hypertrophy and heart failure. Treatment of anemia reduces morbidity and mortality risks and may improve quality of life.
Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure participants, and have improved the management of anemia over alternatives such as transfusion. Peginesatide (hematide) is a parenteral formulation being developed for the correction of anemia in patients with chronic renal failure, and binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.
Participants in this study received variable doses of peginesatide injection once every four weeks. Total commitment time for this study was about 30 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginesatide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginesatide | Drug | Peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24). | Baseline and Week 19 to Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period | Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction. | Week 19 to Week 24 |
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Inclusion Criteria:
The patient was a man or woman 18 to 90 years of age, inclusive.
The patient had CKD and met 1 of the following criteria:
The patient was on stable darbepoetin alfa maintenance therapy (either SC or IV) continuously for a minimum of 8 weeks prior to enrollment.
The patient had 4 consecutive Hb values with a mean ≥10.0 and ≤12.0 g/dL during screening period, with the difference between the mean of the first 2 consecutive Hb values and the mean of the last 2 consecutive values being ≤1.0 g/dL.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
Participants with a diagnosis of chronic renal failure (on hemodialysis or not on dialysis) and receiving stable Darbepoetin alfa maintenance therapy were enrolled into one treatment group (peginesatide injection).
Participants enrolled at 18 investigative sites in the United Kingdom, Italy, Australia, and the United States from 22 September 2008 to 24 December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginesatide - On Dialysis | Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL | Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction. | Baseline and Week 19 to Week 24. |
| Percentage of Participants With Red Blood Cell Transfusions | The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. | Up to 24 weeks. |
| Mean Hemoglobin During 4-week Intervals | Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). | Up to 24 weeks. |
| Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. | Up to 24 weeks. |
| Percentage of Participants With Dose Adjustments During the Study | The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose. | From Week 4 to Week 20 |
| Sacramento |
| California |
| United States |
| San Diego | California | United States |
| Middlebury | Connecticut | United States |
| Lauderdale Lakes | Florida | United States |
| Shreveport | Louisiana | United States |
| Dearborn | Michigan | United States |
| Columbus | Mississippi | United States |
| Mineola | New York | United States |
| Arlington | Texas | United States |
| FG001 | Peginesatide - Not on Dialysis | Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. |
| Full Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginesatide - On Dialysis | Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. |
| BG001 | Peginesatide - Not on Dialysis | Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Baseline characteristics are reported for the Full Analysis Set. | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 Change in Hemoglobin Between Baseline and the Evaluation Period | Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24). | The Full Analysis Set including all patients who received at least 1 dose of study drug where data was available (indicated by N). | Posted | Mean | Standard Deviation | g/dL | Baseline and Week 19 to Week 24. |
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| Secondary | Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period | Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction. | Full Analysis Set where data was available. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 19 to Week 24 |
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| Secondary | Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL | Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction. | Full analysis set where data was available. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 19 to Week 24. |
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| Secondary | Percentage of Participants With Red Blood Cell Transfusions | The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. | Full Analysis Set. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 weeks. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Hemoglobin During 4-week Intervals | Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). | Full Analysis Set where data was available for each time interval (indicated by N). | Posted | Mean | Standard Deviation | g/dL | Up to 24 weeks. |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. | Full analysis set where data was available for each time interval (indicated by N). | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 weeks. |
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| Secondary | Percentage of Participants With Dose Adjustments During the Study | The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose. | Safety Analysis set, which included all patients who received at least 1 dose of study drug. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations. | Posted | Number | percentage of participants | From Week 4 to Week 20 |
|
Treatment-emergent adverse events are adverse events that occurred on or after the day of the first dose of peginesatide injection through the Follow-up phone call, which occurred within 28 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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 - On Dialysis | Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. | 16 | 52 | 31 | 52 | ||
| EG001 | Peginesatide - Not on Dialysis | Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. | 6 | 49 | 28 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Dermo-hypodermitis | Infections and infestations | MedDRA v. 12.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA v. 12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v. 12.1 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA v. 12.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v. 12.1 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA v. 12.1 | Systematic Assessment |
| |
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA v. 12.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v. 12.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v. 12.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v. 12.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 12.1 | Systematic Assessment | This treatment-emergent death occured during titration period and is not related. |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Diabetic neuropathy | Nervous system disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Ischaemic cerebral infarction | Nervous system disorders | MedDRA v. 12.1 | Systematic Assessment | This treatment-emergent death occured during titration period and is not related. |
|
| Renal failure acute | Renal and urinary disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Aortic valve replacement | Surgical and medical procedures | MedDRA v. 12.1 | Systematic Assessment |
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| Peripheral vascular disorder | Vascular disorders | MedDRA v. 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v. 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Consitpation | Gastrointestinal disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Astenia | General disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Injection Site Extravasation | General disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA v. 12.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA v. 12.1 | Systematic Assessment |
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| Thrombosis in Device | Injury, poisoning and procedural complications | MedDRA v. 12.1 | Systematic Assessment |
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| Vascular Graft Complication | Injury, poisoning and procedural complications | MedDRA v. 12.1 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v. 12.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v. 12.1 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C556270 | peginesatide |
| C514771 | hematide |
Not provided
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| ≥65 - <75 years |
|
| ≥ 75 |
|
| Male |
|
| Change from Baseline [N=45, 47] |
|
| Mean change from baseline |
| 0.49 |
| 2-Sided |
| 95 |
| 0.26 |
| 0.71 |
A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution. |
| No |
| Superiority or Other |
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
|
|
|
| OG002 | Peginesatide - Not on Dialysis | Participants not on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. |
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