- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00372489
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD
An Open-Label, Multi-Center, Extension Study to Evaluate the Safety and Tolerability of Peginesatide for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 (ESAs).
Study participants had received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study (NCT00228449) and were to receive doses of peginesatide for approximately 54 months. However, the Sponsor ended the study early.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arkansas
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Pine Bluff, Arkansas, United States, 71603
- Research Facility
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California
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Mountain View, California, United States, 94041
- Research Facility
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Florida
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Lauderdale Lakes, Florida, United States, 33313
- Research Facility
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Pembroke Pines, Florida, United States, 33028
- Research Facility
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Louisiana
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Shreveport, Louisiana, United States, 71101
- Research Facility
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Michigan
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Detroit, Michigan, United States, 48202
- Research Facility
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Ohio
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Canton, Ohio, United States, 44718
- Research Facility
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Tennessee
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Nashville, Tennessee, United States, 37205
- Research Facility
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Texas
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San Antonio, Texas, United States, 78215
- Research Facility
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 drug administration, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug.
- Participant who has received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study
- One hemoglobin value of > 10.0 g/dL in the 4 weeks prior to study drug administration
Exclusion Criteria:
- Known intolerance to peginesatide or pegylated products
- History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA)
- High likelihood of early withdrawal or interruption of the study (e.g., participant suffers from any clinically significant medical disease or condition that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the participant)
- Anticipated life expectancy < 18 months
- Receipt of any ESA other than peginesatide at any time after participant enrollment in the previous Affymax-sponsored study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Peginesatide
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Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled.
The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg.
Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change
Time Frame: Up to 54 months
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Up to 54 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFX01-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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AffymaxCompletedAnemia | Chronic Kidney Disease | Chronic Renal FailureBulgaria, Romania, United Kingdom
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AffymaxTerminatedAnemia | Chronic Kidney Disease | Chronic Renal FailureBulgaria, Romania, Poland, United Kingdom
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AffymaxTerminatedAnemia | Chronic Kidney Disease | Chronic Renal FailureUnited Kingdom
-
AffymaxCompletedCancer | Chemotherapy Induced AnemiaCzech Republic, Poland, United Kingdom
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AffymaxCompletedCancer | Anemia | Chronic Kidney Disease | Chronic Renal FailureUnited Kingdom
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AmgenTerminated
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TakedaCompletedAnemia | Chronic Kidney Disease | Pure Red Cell Aplasia | Chronic Renal FailureUnited Kingdom, France, Germany