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

Information source: Affymax
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Renal Failure; Chronic Kidney Disease; Anemia

Intervention: peginesatide (Drug); Epoetin alfa or Epoetin beta (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Affymax

Official(s) and/or principal investigator(s):
Vice President, Clinical Development, Study Director, Affiliation: Affymax

Summary

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

Clinical Details

Official title: AFX01-14: 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

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

Primary outcome: Mean Change in Hemoglobin Between Baseline and the Evaluation Period

Secondary outcome:

Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods

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)

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 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 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 injection, a composite safety endpoint (CSE) was defined for use in prospectively planned analyses which combined cardiovascular safety data from the four Phase 3 peginesatide injection 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria 1. Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization. 2. On IV epoetin alfa or beta 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 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.

Locations and Contacts

Research Facility, Burgas 8000, Bulgaria

Research Facility, Pazardzhik 4400, Bulgaria

Research Facility, Pleven 5800, Bulgaria

Research Facility, Plovdiv 4000, Bulgaria

Research Facility, Plovdiv 4003, Bulgaria

Research Facility, Rousse 7002, Bulgaria

Research Facilities (2), Sofia 1431, Bulgaria

Research Facility, Sofia 1309, Bulgaria

Research Facility, Sofia 1527, Bulgaria

Research Facility, Sofia 1606, Bulgaria

Research Facility, Varna 9010, Bulgaria

Research Facility, Veliko Tarnovo 5000, Bulgaria

Research Facility, Amiens Cedex 1 80054, France

Research Facility, Bordeaux 33000, France

Research Facility, Montpellier Cedex 5 34295, France

Research Facility, Vannes 56017, France

Research Facilities (2), Bremen 28359, Germany

Research Facility, Franfurt 60528, Germany

Research Facility, Hamburg 22297, Germany

Research Facility, Kaiserslautern 67655, Germany

Research Facility, Como 22100, Italy

Research Facility, Cremona 26100, Italy

Research Facility, Lecco 23900, Italy

Research Facility, Modena 41100, Italy

Research Facility, Prato 59100, Italy

Research Facility, Ciechanow 06-400, Poland

Research Facility, Katowice 40-027, Poland

Research Facility, Pabianice 95-200, Poland

Research Facility, Wloclawek 87-800, Poland

Research Facility, Bucuresti 014461, Romania

Research Facility, Bucuresti 050098, Romania

Research Facility, Iasi 700503, Romania

Research Facility, Alicante 03010, Spain

Research Facility, Barcelona 08025, Spain

Research Facility, Barcelona 08902, Spain

Research Facility, Barcelona 08907, Spain

Research Facility, Ciudad Real 13005, Spain

Research Facility, Madrid 28922, Spain

Research Facility, Madrid 28041, Spain

Research Facility, Santander 39008, Spain

Research Facility, Carshalton SM5 1AA, United Kingdom

Research Facility, London SW17 0QT, United Kingdom

Research Facility, London SE5 9RS, United Kingdom

Research Facility, London E1 1BB, United Kingdom

Research Facility, Swansea SA6 6NL, United Kingdom

Research Facility, Phoenix, Arizona 85012, United States

Research Facility, Hot Springs, Arkansas 71901, United States

Research Facility, McGehee, Arkansas 71654, United States

Research Facility, Pine Bluff, Arkansas 71603, United States

Research Facility, Bakersfield, California 93309, United States

Research Facility, Glendale, California 91205, United States

Research Facility, Los Angeles, California 90033, United States

Research Facility, Los Angeles, California 90048, United States

Research Facility, Los Angeles, California 90073, United States

Research Facility, Riverside, California 92505, United States

Research Facility, Simi Valley, California 93065, United States

Research Facility, Whittier, California 90602, United States

Research Facility, Yuba City, California 95991, United States

Research Facility, Westminster, Colorado 80031, United States

Research Facility, Lauderdale Lakes, Florida 33313, United States

Research Facility, Miami, Florida 33173, United States

Research Facility, Pinecrest, Florida 33156, United States

Research Facility, Flossmoor, Illinois 60422, United States

Research Facility, Hines, Illinois 60141, United States

Research Facility, Louisville, Kentucky 40202, United States

Research Facility, Rockville, Maryland 20850, United States

Research Facility, Springfield, Massachusetts 01107, United States

Research Facility, Detroit, Michigan 48236, United States

Research Facility, Detroit, Michigan 48202, United States

Research Facility, Brookhaven, Mississippi 39601, United States

Research Facility, Bronx, New York 10461, United States

Research Facility, Brooklyn, New York 11238, United States

Research Facility, Flushing, New York 11355, United States

Research Facility, Asheville, North Carolina 28801, United States

Research Facility, Toledo, Ohio 43606, United States

Research Facility, Oklahoma City, Oklahoma 73116, United States

Research Facility, Erie, Pennsylvania 16507, United States

Research Facility, Philadelphia, Pennsylvania 19141, United States

Research Facility, Providence, Rhode Island 02904, United States

Research Facility, Orangeburg, South Carolina 29118, United States

Research Facility, Arlington, Texas 76015, United States

Research Facility, Houston, Texas 77099, United States

Research Facility, San Antonio, Texas 78215, United States

Research Facility, Fairfax, Virginia 22033, United States

Additional Information

FDA Briefing Document for the Oncologic Drugs Advisory Committee (ODAC) - December 7, 2011 for peginesatide injection

Starting date: October 2007
Last updated: March 6, 2013

Page last updated: August 23, 2015

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