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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00453973 |
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Date of registration:
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27/03/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)
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Scientific title:
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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 |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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114 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00453973 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Bulgaria
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Poland
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Romania
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United Kingdom
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Contacts
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Name:
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Vice President, Clinical Development |
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Address:
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Telephone:
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Email:
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Affiliation:
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Affymax |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participant is informed of the investigational nature of this study and has given
written, informed consent in accordance with institutional, local, and national
guidelines.
- Males or females = 18 years of age.
- Premenopausal 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 grams per deciliter (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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anemia
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Chronic Kidney Disease
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Chronic Renal Failure
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Intervention(s)
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Drug: peginesatide
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Primary Outcome(s)
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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 Final Dosing Guideline Change
[Time Frame: Up to 54 months]
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Secondary ID(s)
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AFX01-10
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2006-003846-41
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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