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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.
Erythropoiesis stimulating agents (ESAs) have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia in patients with chronic kidney disease. Peginesatide 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.
Eligible participants were randomized in equal proportions to two peginesatide treatment regimens, in which participants received peginesatide once every 4 weeks, and one control, epoetin alfa, treatment regimen, in which participants received epoetin alfa three times per week. Total commitment time of this study was a 4 week screening period followed by a minimum of 7 months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginesatide 0.04 mg/kg | Experimental |
| |
| Peginesatide 0.08 mg/kg | Experimental |
| |
| Epoetin Alfa | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginesatide | Drug | Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hemoglobin Between Baseline and the Evaluation Period | The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28. | Baseline and Weeks 21-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods | Weeks 1 to 28 | |
| Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods | A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Vice President, Clinical Development | Affymax | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Irkutsk | Russia | ||||
| Research Facility |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginesatide 0.04 mg/kg | Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
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| peginesatide | Drug | Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. |
|
|
| Epoetin Alfa | Drug | Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. |
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| Weeks 1 to 28 |
| Krasnodar |
| Russia |
| Research Facility | Krasnoyarsk | Russia |
| Research Facility | Moscow | Russia |
| Research Facility | Nizhny Novgorod | Russia |
| Research Facility | Omsk | Russia |
| Research Facility | Petrozavodsk | Russia |
| Research Facility | Saint Petersburg | Russia |
| Research Facility | Saratov | Russia |
| Research Facility | Tver' | Russia |
| Research Facility | Volzhsk | Russia |
| Peginesatide 0.08 mg/kg |
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. |
| FG002 | Epoetin Alfa | Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginesatide 0.04 mg/kg | Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). |
| BG001 | Peginesatide 0.08 mg/kg | Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. |
| BG002 | Epoetin Alfa | Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28. | Full Analysis Population | Posted | Mean | Standard Deviation | g/dL | Baseline and Weeks 21-28 |
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| Secondary | Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods | Full Analysis Population | Posted | Number | percentage of participants | Weeks 1 to 28 |
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| Secondary | Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods | A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks. | Full Analysis Population | Posted | Number | percentage of participants | Weeks 1 to 28 |
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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 0.04 mg/kg | Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). | 6 | 39 | 21 | 39 | ||
| EG001 | Peginesatide 0.08 mg/kg | Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. | 8 | 37 | 26 | 37 | ||
| EG002 | Epoetin Alfa | Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. | 4 | 38 | 27 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Hepatitis C | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Diabetic foot | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Diabetic vascular disorder | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Extremity necrosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Hyperparathyroidism secondary | Endocrine disorders | MedDRA (11.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Erosive duodenitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Catheter site inflammation | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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The first publication of the primary safety and efficacy results will include data from all appropriate study sites. Either after the first multicenter publication, or following 36 months after the completion of the study, Investigators are free to publish; such publications may not contain Sponsor Confidential Information and may be subject to Sponsor review 60 days prior to submission for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Development | Affymax | 650-812-8700 | info@affymax.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|
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| Change from Baseline [N=37, 37, 36] |
|
| Least Squares Mean Difference |
| -0.02 |
| Standard Error of the Mean |
| 0.238 |
| 2-Sided |
| 97.5 |
| -0.56 |
| 0.52 |
| No |
| Superiority or Other |
| Units |
|---|
| Counts |
|---|
| Participants |
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