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Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372489
Recruitment Status : Terminated (Due to more robust long-term data generated in other active-controlled studies)
First Posted : September 7, 2006
Results First Posted : May 28, 2012
Last Update Posted : June 29, 2012
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Chronic Kidney Disease Anemia Drug: peginesatide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : September 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Peginesatide Drug: peginesatide
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:
  • Omontys
  • Hematide
  • AF37702 Injection

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372489

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United States, Arkansas
Research Facility
Pine Bluff, Arkansas, United States, 71603
United States, California
Research Facility
Mountain View, California, United States, 94041
United States, Florida
Research Facility
Lauderdale Lakes, Florida, United States, 33313
Research Facility
Pembroke Pines, Florida, United States, 33028
United States, Louisiana
Research Facility
Shreveport, Louisiana, United States, 71101
United States, Michigan
Research Facility
Detroit, Michigan, United States, 48202
United States, Ohio
Research Facility
Canton, Ohio, United States, 44718
United States, Tennessee
Research Facility
Nashville, Tennessee, United States, 37205
United States, Texas
Research Facility
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
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Study Director: Vice President, Clinical Development Affymax

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Responsible Party: Affymax Identifier: NCT00372489     History of Changes
Other Study ID Numbers: AFX01-09
First Posted: September 7, 2006    Key Record Dates
Results First Posted: May 28, 2012
Last Update Posted: June 29, 2012
Last Verified: June 2012
Keywords provided by Affymax:
chronic kidney disease
chronic renal failure
erythropoiesis stimulating agent
red blood cell
red blood cell production
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases