Back to resultsPeginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis
Primary Purpose
Anemia, Chronic Kidney Disease, Chronic Renal Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
peginesatide
peginesatide
peginesatide
peginesatide
peginesatide
peginesatide
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring anemia, chronic kidney disease, CKD, chronic renal failure, CRF, dialysis, erythropoietin, EPO, erythropoiesis stimulating agent, ESA, Hematide™, hemodialysis, hemoglobin, Hb, Hgb, Omontys, peginesatide, red blood cell, red blood cell production
Eligibility Criteria
Inclusion Criteria:
- Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines
- 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:
- Pregnant or breast-feeding participants
- 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
Sites / Locations
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1, Q4W, SC, No Transition
Cohort 2, Q4W, IV, No Transition
Cohort 3, Q4W, SC, Transition
Cohort 4, Q4W, IV, Transition
Cohort 5, Q4W, SC, Transition
Cohort 6, Q4W, IV, Transition
Arm Description
Outcomes
Primary Outcome Measures
Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.
The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00434330
Brief Title
Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis
Official Title
A Phase 2, Open-Label, Multi-Center, Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affymax
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to determine the dose ranges of peginesatide administered intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose hemoglobin values were stable on epoetin (alfa or beta).
Detailed Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease, Chronic Renal Failure
Keywords
anemia, chronic kidney disease, CKD, chronic renal failure, CRF, dialysis, erythropoietin, EPO, erythropoiesis stimulating agent, ESA, Hematide™, hemodialysis, hemoglobin, Hb, Hgb, Omontys, peginesatide, red blood cell, red blood cell production
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1, Q4W, SC, No Transition
Arm Type
Experimental
Arm Title
Cohort 2, Q4W, IV, No Transition
Arm Type
Experimental
Arm Title
Cohort 3, Q4W, SC, Transition
Arm Type
Experimental
Arm Title
Cohort 4, Q4W, IV, Transition
Arm Type
Experimental
Arm Title
Cohort 5, Q4W, SC, Transition
Arm Type
Experimental
Arm Title
Cohort 6, Q4W, IV, Transition
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702 Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702 Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702 Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702 Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702 Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702 Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.
Description
The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period.
Time Frame
Baseline and Weeks 2-29
Other Pre-specified Outcome Measures:
Title
Proportion of Participants With Hemoglobin Within 1.0 g/dL Below Baseline to 1.5 g/dL Above Baseline Throughout the Trial (Weeks 2-29)
Description
Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within 1 g/dL below to 1.5 g/dL above baseline) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.
Time Frame
Weeks 2 to 29
Title
Proportion of Participants Who Maintained Hemoglobin Within 10 to 12.5 g/dL Throughout the Trial
Description
Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 10 g/dL to 12.5 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.
Time Frame
Weeks 2 to 29
Title
Proportion of Participants Who Maintain Hemoglobin Within 9.5 to 13.0 g/dL Throughout the Trial
Description
Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 9.5 g/dL to 13.0 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.
Time Frame
Weeks 2 to 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines
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:
Pregnant or breast-feeding participants
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vice President, Clinical Development
Organizational Affiliation
Affymax, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Research Facility
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Research Facility
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Research Facility
City
Rousse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Research Facility
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Research Facility
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Research Facility
City
Sofia
ZIP/Postal Code
1709
Country
Bulgaria
Facility Name
Research Facility
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Research Facility
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Research Facility
City
Arad
ZIP/Postal Code
310017
Country
Romania
Facility Name
Research Facility
City
Bacau
ZIP/Postal Code
600114
Country
Romania
Facility Name
Research Facility
City
Bucuresti
Country
Romania
Facility Name
Research Facility
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Research Facility
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Research Facility
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis
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