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NCT00597753 Clinical Trial

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

Anemia Clinical Trial

— EMERALD 1  

Official title:
AFX01-12: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin Alfa

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00597753
Other study ID # AFX01-12
Secondary ID
Status Completed
Phase Phase 3
First received January 10, 2008
Last updated February 6, 2013
Start date September 2007
Est. completion date January 2010

Study information
Verified date February 2013
Source Affymax
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.

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 chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia in patients 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.

Eligible participants were randomized in a 2:1 ratio to peginesatide administered once every 4 weeks or to continued treatment with epoetin alfa administered 1-3 times each week, respectively. Total commitment time for this study was 4 weeks of screening followed by a minimum of 52 weeks of study treatment.

To evaluate the cardiovascular safety of peginesatide, a cardiovascular composite safety endpoint (CSE) was defined for use in prospectively planned analyses which combined cardiovascular safety data from the four Phase 3 peginesatide studies (NCT00598273, NCT00597753, NCT00598442, and NCT00597584). The CSE consisted of six events: death, stroke, myocardial infarction, and serious adverse events of congestive heart failure, unstable angina, and arrhythmia. An independent Event Review Committee (ERC) was used to provide blinded adjudication of potential CSE events.

Recruitment information / eligibility
Status Completed
Enrollment 803
Est. completion date January 2010
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

1. Participants with chronic renal failure on hemodialysis for = 3 months prior to randomization.

2. On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.

3. Four consecutive hemoglobin values with a mean = 10.0 and = 12.0 g/dL during the screening period

Exclusion Criteria

1. Females who are pregnant or breast-feeding.

2. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.

3. Known bleeding or coagulation disorder.

4. Known hematologic disease or cause of anemia other than renal disease

5. Poorly controlled hypertension

6. Evidence of active malignancy within one year prior to randomization.

7. Temporary (untunneled) dialysis access catheter.

8. A scheduled kidney transplant

9. A scheduled surgery that may be expected to lead to significant blood loss.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• peginesatide
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
• Epoetin Alfa
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.

Locations
Country Name City State
United States Research Facility Alexandria Virginia
United States Research Facility Allentown Pennsylvania
United States Research Facility Appleton Wisconsin
United States Research Facility Arlington Texas
United States Research Facility Augusta Georgia
United States Research Facility Augusta Georgia
United States Research Facility Baton Rouge Louisiana
United States Research Facility Bethesda Maryland
United States Research Facility Boise Idaho
United States Research Facility Bronx New York
United States Research Facility Bronx New York
United States Research Facility Brooklyn New York
United States Research Facility Canton Ohio
United States Research Facility Chesapeake Virginia
United States Research Facility Chicago Illinois
United States Research Facility Cincinnati Ohio
United States Research Facility Columbus Ohio
United States Research Facility Columbus Mississippi
United States Research Facility Dearborn Michigan
United States Research Facility Decatur Georgia
United States Research Facility Denver Colorado
United States Research Facility Durham North Carolina
United States Research Facility Dyersburg Tennessee
United States Research Facility Eatontown New Jersey
United States Research Facility Evansville Indiana
United States Research Facility Evergreen Park Illinois
United States Research Facility Fairfax Virginia
United States Research Facility Fairfield California
United States Research Facility Fall River Massachusetts
United States Research Facility Fort Worth Texas
United States Research Facility Fort Worth Texas
United States Research Facility Fort Worth Texas
United States Research Facility Granada Hills California
United States Research Facility Grand Prairie Texas
United States Research Facilities (2) Greenville South Carolina
United States Research Facility Gurnee Illinois
United States Research Facility Honolulu Hawaii
United States Research Facilities (2) Houston Texas
United States Research Facility Houston Texas
United States Research Facility Hudson Florida
United States Research Facility Kalamazoo Michigan
United States Research Facility Knoxville Tennessee
United States Research Facility Lafayette Louisiana
United States Research Facility Las Vegas Nevada
United States Research Facility Lexington Kentucky
United States Research Facility Los Alamitos California
United States Research Facility Los Angeles California
United States Research Facility Los Angeles California
United States Research Facility Los Angeles California
United States Research Facility Lynwood California
United States Research Facility Marietta Georgia
United States Research Facility McAllen Texas
United States Research Facility Mechanicsville Virginia
United States Research Facility Middlebury Connecticut
United States Research Facility Monterey Park California
United States Research Facility Morgantown West Virginia
United States Research Facility Mountain View California
United States Research Facility Nashville Tennessee
United States Research Facility New Orleans Louisiana
United States Research Facility New York New York
United States Research Facilities (2) Norfolk Virginia
United States Research Facility Ocala Florida
United States Research Facility Orlando Florida
United States Research Facility Orlando Florida
United States Research Facility Oshkosh Wisconsin
United States Research Facility Paragould Arkansas
United States Research Facility Paramount California
United States Research Facility Pembroke Pines Florida
United States Research Facility Peoria Illinois
United States Research Facility Philadelphia Pennsylvania
United States Research Facility Philadelphia Pennsylvania
United States Research Facility Pittsburgh Pennsylvania
United States Research Facility Raleigh North Carolina
United States Research Facility Rockville Maryland
United States Research Facility Roseburg Oregon
United States Research Facility San Antonio Texas
United States Research Facility San Antonio Texas
United States Research Facilities (2) San Diego California
United States Research Facility San Dimas California
United States Research Facility Shreveport Louisiana
United States Research Facility St. Louis Missouri
United States Research Facility Sumter South Carolina
United States Research Facility Tupelo Mississippi
United States Research Facility Tyler Texas
United States Research Facility Whittier California
United States Research Facility Wichita Kansas
United States Research Facility Williamsville New York
United States Research Facility Worcester Massachusetts
United States Research Facility Yonkers New York

Sponsors (2)
Lead Sponsor Collaborator
Affymax Takeda

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A; EMERALD Study Groups. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Me — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change in Hemoglobin Between Baseline and the Evaluation Period The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36. Baseline and Weeks 29-36 No
Secondary Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods Weeks 0 to 36 No
Secondary Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL) Weeks 29 to 36 No
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