Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis
NCT ID: NCT00434330
Last Updated: 2012-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2006-12-31
2008-04-30
Brief Summary
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Detailed Description
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Erythropoiesis stimulating agents have been established as a treatment for anemia in subjects with chronic kidney disease, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia associated 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.
Six dose cohorts of 15 participants each were evaluated in this study. Participants received peginesatide injection once every 4 weeks administered intravenously or subcutaneously for a total of 7 doses.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1, Q4W, SC, No Transition
peginesatide
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
Cohort 2, Q4W, IV, No Transition
peginesatide
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
Cohort 3, Q4W, SC, Transition
peginesatide
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
Cohort 4, Q4W, IV, Transition
peginesatide
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
Cohort 5, Q4W, SC, Transition
peginesatide
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
Cohort 6, Q4W, IV, Transition
peginesatide
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
Interventions
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peginesatide
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
peginesatide
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
peginesatide
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
peginesatide
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
peginesatide
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
peginesatide
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males or females ≥ 18 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study start, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug
* Clinically stable on hemodialysis for ≥ 3 months prior to study start
* Epoetin (alfa or beta) maintenance therapy, ≥ 50 and ≤ 200 Units/kg/week, at the same dosing frequency, continuously prescribed for 8 weeks prior to study start
* Three mid- or end-of-week hemoglobin values of ≥ 10.0 and ≤ 12.5 grams per deciliter (g/dL) in the 4 weeks prior to study start, with ≤ 1.2 g/dL difference between any of the three values
* One transferrin saturation (TSAT) \> 20% within 4 weeks prior to study start
* One ferritin level ≥ 100 ng/mL within 4 weeks prior to study start
* One serum or red cell folate level ≥ lower limit of normal during the 4 weeks prior to study start
* One vitamin B12 level ≥ lower limit of normal during the 4 weeks prior to study start
* One C-reactive protein (CRP) level ≤ 30 mg/L within 4 weeks prior to study start
* Urea clearance/volume (Kt/V) ≥ 1.2 within 4 weeks prior to study start
* One white blood cell count (WBC) ≥ 3.0 x 10\^9/L within 4 weeks prior to study start
* One platelet count ≥ 100 x 10\^9/L and ≤ 500 x 10\^9/L within 4 weeks prior to study start
Exclusion Criteria
* Known intolerance to any erythropoiesis stimulating agent, parenteral iron supplementation or pegylated molecules
* History of antibodies to any erythropoiesis stimulating agent or history of pure red cell aplasia (PRCA)
* Known bleeding or coagulation disorder
* Known hematologic disease (e.g., homozygous sickle-cell disease, thalassemia of all types, multiple myeloma, hemolytic anemia)
* Uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.)
* Known history of seizure disorder or received anti-epileptic medication within the previous 6 months
* Uncontrolled or symptomatic secondary hyperparathyroidism, per Investigator's clinical judgment
* Poorly controlled hypertension within 4 weeks prior to study start, per Investigator's clinical judgment
* Chronic congestive heart failure of New York Heart Association class III or IV
* High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric, or neurological abnormalities, liver disease including active hepatitis B or C, active HIV disease, or any other clinically significant medical diseases or conditions in the prior 6 months that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the participant)
* Evidence of malignancy within the past 5 years (except non-melanoma skin cancer which is not an exclusion criterion)
* Life expectancy \< 12 months
* Temporary (untunneled) dialysis access catheter
* Anticipated elective surgery during the study period, that may be expected to lead to significant blood loss, including vascular access surgery such as an arteriovenous fistula or graft, or a scheduled kidney transplant
* Red blood cell or whole blood transfusion within 12 weeks prior to study start
* Received antibiotics for systemic infection within 2 weeks prior to study start
* Previous exposure to any investigational agent within 6 weeks prior to study start, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period
18 Years
ALL
No
Sponsors
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Affymax
INDUSTRY
Responsible Party
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Principal Investigators
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Vice President, Clinical Development
Role: STUDY_DIRECTOR
Affymax, Inc.
Locations
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Research Facility
Burgas, , Bulgaria
Research Facility
Pleven, , Bulgaria
Research Facility
Plovdiv, , Bulgaria
Research Facility
Rousse, , Bulgaria
Research Facility
Sofia, , Bulgaria
Research Facility
Sofia, , Bulgaria
Research Facility
Sofia, , Bulgaria
Research Facility
Varna, , Bulgaria
Research Facility
Veliko Tarnovo, , Bulgaria
Research Facility
Arad, , Romania
Research Facility
Bacau, , Romania
Research Facility
Bucharest, , Romania
Research Facility
Iași, , Romania
Research Facility
Timișoara, , Romania
Research Facility
London, , United Kingdom
Countries
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Other Identifiers
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2006-002815-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AFX01-07
Identifier Type: -
Identifier Source: org_study_id