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Trial record 1 of 1 for:    AFX01-10
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Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)

This study has been terminated.
(Due to more robust long-term data generated in other active-controlled studies)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00453973
First Posted: March 29, 2007
Last Update Posted: June 29, 2012
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.
Information provided by (Responsible Party):
Affymax
  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: Allocation: Non-Randomized
Intervention Model: Parallel 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

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 Final Dosing Guideline Change [ Time Frame: Up to 54 months ]

Enrollment: 114
Study Start Date: November 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maintenance Switch in Dialysis Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study.
Drug: peginesatide
Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Treatment Initiation in Non-Dialysis Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.
Drug: peginesatide
Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. Each participant was to receive peginesatide as an injection administered 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 (ESAs) 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.

Study participants had received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study and were to receive doses of peginesatide for up to 54 months. However, the Sponsor ended the study early.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00453973


Locations
Bulgaria
Research Facility
Burgas, Bulgaria, 8000
Research Facility
Pleven, Bulgaria, 5800
Research Facility
Plovdiv, Bulgaria, 4003
Research Facility
Rousse, Bulgaria, 7002
Research Facility
Varna, Bulgaria, 9010
Research Facility
Veliko Tarnovo, Bulgaria, 5000
Poland
Research Facility
Białystok, Poland, 15-540
Research Facility
Katowice, Poland, 40-027
Research Facility
Łódź, Poland, 90-153
Romania
Research Facility
Arad, Romania, 310017
Research Facility
Bacau, Romania, 600114
Research Facility
Bucuresti, Romania, 014461
Research Facility
Iasi, Romania, 700506
Research Facility
Timisoara, Romania, 300736
United Kingdom
Research Facility
Croydon, United Kingdom, CR7 7YE
Research Facility
Derby, United Kingdom, DE22 3NE
Research Facility
London, United Kingdom, E1 1BB
Research Facility
London, United Kingdom, SES 9RS
Research Facility
London, United Kingdom, SW17 0QT
Research Facility
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Affymax
Investigators
Study Director: Vice President, Clinical Development Affymax
  More Information

Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00453973     History of Changes
Other Study ID Numbers: AFX01-10
2006-003846-41 ( EudraCT Number )
First Submitted: March 27, 2007
First Posted: March 29, 2007
Results First Submitted: April 26, 2012
Results First Posted: May 28, 2012
Last Update Posted: June 29, 2012
Last Verified: June 2012

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:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Hematinics