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Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

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); peginesatide (Drug); Darbepoetin alfa (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 for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.

Clinical Details

Official title: AFX01-11: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment

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 Correction and Evaluation Periods

Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods.

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 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. Study participants received doses of peginesatide administered once every 4 weeks or darbepoetin alfa administered once every 2 weeks. Total commitment time for this study was a 4 week screening period followed by a minimum of 52 weeks of study treatment. Eligible participants were randomized in equal proportions to two peginesatide treatment regimens and one control, darbepoetin alfa, treatment regimen. 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.

Eligibility

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

Criteria:

Inclusion Criteria: 1. Chronic renal failure with an estimated glomerular filtration rate < 60 milliliter per minute per 1. 73m^2 and not expected to begin dialysis for at least 12 weeks. 2. Two consecutive hemoglobin values ≥ 8. 0 g/dL and < 11. 0 g/dL within 4 weeks prior to randomization. Exclusion Criteria: 1. Females who are pregnant or breast-feeding. 2. Treatment with an ESA in the 12 weeks prior to randomization. 3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule. 4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment. 5. Known bleeding or coagulation disorder. 6. Known hematologic disease or cause of anemia other than renal disease 7. Poorly controlled hypertension 8. Evidence of active malignancy within one year prior to randomization. 9. A scheduled kidney transplant

Locations and Contacts

Research Facility, Caguas 00725, Puerto Rico

Research Facility, Ponce 00716, Puerto Rico

Research Facility, San Juan 00909, Puerto Rico

Research Facility, San Juan 00918, Puerto Rico

Research Facility, Montgomery, Alabama 36106, United States

Research Facility, Tempe, Arizona 85306, United States

Research Facility, Hot Springs, Arkansas 71901, United States

Research Facility, Bakersfield, California 93309, United States

Research Facility, Chula Vista, California 91910, United States

Research Facility, Glendale, California 91204, United States

Research Facility, Huntington Beach, California 92646, United States

Research Facility, Los Angeles, California 90095, United States

Research Facility, Orange, California 92868, United States

Research Facility, Paramount, California 90723, United States

Research Facility, Pasadena, California 91106, United States

Research Facility, Riverside, California 92505, United States

Research Facility, San Dimas, California 91773, United States

Research Facility, Stanford, California 94305-6203, United States

Research Facility, Whittier, California 90603, United States

Research Facility, Whittier, California 90606, United States

Research Facility, Yuba City, California 95991, United States

Research Facility, Thornton, Colorado 80031, United States

Research Facility, Washington, District of Columbia 20037, United States

Research Facility, Holly Hill, Florida 32117, United States

Research Facility, Hudson, Florida 34667, United States

Research Facility, Miami, Florida 33173, United States

Research Facility, Ocala, Florida 34471, United States

Research Facility, Orlando, Florida 32804, United States

Research Facility, Tampa, Florida 33614, United States

Research Facility, Augusta, Georgia 30901, United States

Research Facility, Honolulu, Hawaii 96817, United States

Research Facility, Chicago, Illinois 60616, United States

Research Facility, Evergreen Park, Illinois 60805, United States

Research Facility, Hines, Illinois 60141, United States

Research Facility, Evansville, Indiana 47714, United States

Research Facility, Lafayette, Indiana 47904, United States

Research Facility, Wichita, Kansas 67214, United States

Research Facility, Shreveport, Louisiana 71101, United States

Research Facility, Bethesda, Maryland 20814, United States

Research Facility, Fall River, Massachusetts 02720, United States

Research Facility, Worcester, Massachusetts 01608, United States

Research Facility, Midland, Michigan 48640, United States

Research Facility, Columbus, Mississippi 39705, United States

Research Facility, Kansas City, Missouri 64128, United States

Research Facility, Northfield, New Jersey 08225, United States

Research Facility, Toms River, New Jersey 08755, United States

Research Facility, Binghamton, New York 13903, United States

Research Facility, Great Neck, New York 11021, United States

Research Facility, Mineola, New York 11501, United States

Research Facility, Charlotte, North Carolina 28208, United States

Research Facility, Oklahoma City, Oklahoma 73116, United States

Research Facility, Bend, Oregon 97701, United States

Research Facility, Portland, Oregon 97210, United States

Research Facility, Allentown, Pennsylvania 18103, United States

Research Facility, Erie, Pennsylvania 16507, United States

Research Facility, Johnstown, Pennsylvania 15905, United States

Research Facility, Providence, Rhode Island 02904, United States

Research Facility, Orangeburg, South Carolina 29118, United States

Research Facility, Rock Hill, South Carolina 29732, United States

Research Facility, Clarksville, Tennessee 37043, United States

Research Facility, Knoxville, Tennessee 37923, United States

Research Facility, Nashville, Tennessee 37205, United States

Research Facility, Austin, Texas 78705, United States

Research Facility, Corpus Christi, Texas 78404, United States

Research Facility, Corsicana, Texas 75110, United States

Research Facility, Edinburg, Texas 78539, United States

Research Facility, Houston, Texas 77030, United States

Research Facility, Houston, Texas 77099, United States

Research Facility, San Antonio, Texas 78215, United States

Research Facility, San Antonio, Texas 78229, United States

Research Facility, Salem, Virginia 24153, United States

Research Facility, Bluefield, West Virginia 24701, 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: February 6, 2013

Page last updated: August 23, 2015

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