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

Primary Purpose

Chronic Renal Failure, Chronic Kidney Disease, Anemia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
peginesatide
peginesatide
Sponsored by
Affymax
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Facility
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Maintenance Switch in Dialysis Participants

Treatment Initiation in Non-Dialysis Participants

Arm Description

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.

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.

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
March 27, 2007
Last Updated
June 22, 2012
Sponsor
Affymax
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1. Study Identification

Unique Protocol Identification Number
NCT00453973
Brief Title
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Due to more robust long-term data generated in other active-controlled studies
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affymax

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure, Chronic Kidney Disease, Anemia
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maintenance Switch in Dialysis Participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Initiation in Non-Dialysis Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702 Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702 Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vice President, Clinical Development
Organizational Affiliation
Affymax
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Research Facility
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Research Facility
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Research Facility
City
Rousse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Research Facility
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Research Facility
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Research Facility
City
Białystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Research Facility
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
Research Facility
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Research Facility
City
Arad
ZIP/Postal Code
310017
Country
Romania
Facility Name
Research Facility
City
Bacau
ZIP/Postal Code
600114
Country
Romania
Facility Name
Research Facility
City
Bucuresti
ZIP/Postal Code
014461
Country
Romania
Facility Name
Research Facility
City
Iasi
ZIP/Postal Code
700506
Country
Romania
Facility Name
Research Facility
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Research Facility
City
Croydon
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Facility Name
Research Facility
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
SES 9RS
Country
United Kingdom
Facility Name
Research Facility
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Research Facility
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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