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

This study has been terminated.
(Due to more robust long-term data generated in other active-controlled studies)
Sponsor:
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00372489
First received: September 5, 2006
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Chronic Renal Failure
Chronic Kidney Disease
Anemia
Drug: peginesatide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Affymax:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: September 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372489

Locations
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
Affymax
Investigators
Study Director: Vice President, Clinical Development Affymax
  More Information

No publications provided

Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00372489     History of Changes
Other Study ID Numbers: AFX01-09
Study First Received: September 5, 2006
Results First Received: April 26, 2012
Last Updated: June 22, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Affymax:
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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Anemia
Kidney Failure, Chronic
Urologic Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014