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Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis (PEARL 2)

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00598442
First received: January 10, 2008
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Chronic Renal Failure
Chronic Kidney Disease
Anemia
Drug: peginesatide
Drug: Darbepoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AFX01-13: 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

Resource links provided by NLM:


Further study details as provided by Affymax:

Primary Outcome Measures:
  • Mean Change in Hemoglobin Between Baseline and the Evaluation Period [ Time Frame: Baseline and Weeks 25-36 ] [ Designated as safety issue: No ]
    The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two 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 25 through 36.


Secondary Outcome Measures:
  • Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods [ Time Frame: Weeks 0 to 36 ] [ Designated as safety issue: No ]
  • Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods [ Time Frame: Weeks 0 to 36 ] [ Designated as safety issue: No ]
    A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.


Enrollment: 493
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peginesatide 0.025 mg/kg Drug: peginesatide
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Peginesatide 0.04 mg/kg Drug: peginesatide
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Active Comparator: Darbepoetin alfa Drug: Darbepoetin alfa
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Other Name: Aranesp

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chronic renal failure with an estimated glomerular filtration rate < 60 milliliters per minute per 1.73 m^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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598442

  Hide Study Locations
Locations
United States, Arizona
Research Facility
Phoenix, Arizona, United States, 85012
United States, Arkansas
Research Facility
Fayetteville, Arkansas, United States, 72703
United States, California
Research Facility
Fountain Valley, California, United States, 92708
Research Facility
Fullerton, California, United States, 92835
Research Facility
Granada Hills, California, United States, 91344
Research Facility
Los Angeles, California, United States, 90022
Research Facility
San Diego, California, United States, 92123
Research Facility
Whittier, California, United States, 90603
United States, Florida
Research Facility
Lauderdale Lakes, Florida, United States, 33313
Research Facility
Pembroke Pines, Florida, United States, 33028
Research Facility
Pinecrest, Florida, United States, 33156
United States, Georgia
Research Facility
Canton, Georgia, United States, 30114
Research Facility
Columbus, Georgia, United States, 31904
Research Facility
Marietta, Georgia, United States, 30060
United States, Idaho
Research Facility
Caldwell, Idaho, United States, 83605
Research Facility
Meridian, Idaho, United States, 83642
United States, Illinois
Research Facility
Chicago, Illinois, United States, 60611
United States, Indiana
Research Facility
Mishawaka, Indiana, United States, 46545
United States, Iowa
Research Facility
Ames, Iowa, United States, 50010
United States, Louisiana
Research Facility
Baton Rouge, Louisiana, United States, 70809
Research Facility
Lafayette, Louisiana, United States, 70506
United States, Maryland
Research Facility
Rockville, Maryland, United States, 20852
United States, Massachusetts
Research Facility
Springfield, Massachusetts, United States, 01107
United States, Michigan
Research Facility
Detroit, Michigan, United States, 48202
Research Facility
Detroit, Michigan, United States, 48236
Research Facility
Flint, Michigan, United States, 48504
Research Facility
Petoskey, Michigan, United States, 49770
Research Facility
Troy, Michigan, United States, 48098
United States, Missouri
Research Facility
Washington, Missouri, United States, 63090
United States, New York
Research Facility
Flushing, New York, United States, 11355
Research Facility
Williamsville, New York, United States, 14221
United States, North Carolina
Research Facility
Asheville, North Carolina, United States, 28801
United States, Ohio
Research Facility
Columbus, Ohio, United States, 43210
United States, Oregon
Research Facility
Bend, Oregon, United States, 97701
United States, Texas
Research Facility
Arlington, Texas, United States, 76015
Research Facility
Houston, Texas, United States, 77004
Research Facility
San Antonio, Texas, United States, 78229
United States, Vermont
Research Facility
Burlington, Vermont, United States, 05401
United States, Virginia
Research Facility
Fairfax, Virginia, United States, 22030
United States, Washington
Research Facility
Tacoma, Washington, United States, 98405
United States, West Virginia
Research Facility
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Research Facility
Neenah, Wisconsin, United States, 54956
Bulgaria
Research Facility
Sofia, Bulgaria, 1431
Research Facility
Sofia, Bulgaria, 1606
Research Facility
Varna, Bulgaria, 9000
Research Facility
Veliko Tarnovo, Bulgaria, 5000
Czech Republic
Research Facility
Prague, Czech Republic, 14021
Research Facility
Tabor, Czech Republic, 39003
Research Facility
Zdar nad Sazavou, Czech Republic, 591 01
Germany
Research Facility
Demmin, Germany, 17109
Hungary
Research Facility
Balatonfured, Hungary, 8230
Research Facility
Kistarcsa, Hungary, 2143
Research Facility
Szigetvar, Hungary, 7900
Italy
Research Facility
Lecco, Italy, 23900
Research Facility
Pavia, Italy, 27100
Poland
Research Facility
Bialystok, Poland, 15 540
Research Facility
Gdansk, Poland, 80 952
Research Facility
Katowice, Poland, 40 027
Research Facility
Zamosc, Poland, 22 400
Puerto Rico
Research Facility
Ponce, Puerto Rico, 00717-0634
Romania
Research Facility
Iasi, Romania, 700 503
Research Facility
Oradea, Romania, 410469
Research Facility
Timisoara, Romania, 300 736
United Kingdom
Research Facility
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Affymax
Takeda
Investigators
Study Director: Vice President, Clinical Development Affymax
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00598442     History of Changes
Other Study ID Numbers: AFX01-13, 2007-004146-32
Study First Received: January 10, 2008
Results First Received: April 26, 2012
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics committee
Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Hungary: Scientific and Medical Research Council Ethics Committee
Italy: The Italian Medicines Agency
Italy: Ethics Committee
Poland: The Central Register of Clinical Trials
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Romania: National Medicines Agency
Romania: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Affymax:
anemia
chronic kidney disease
CKD
chronic renal failure
CRF
erythropoietin
EPO
erythropoiesis stimulating agent
ESA
Hematide™
hemoglobin
Hb
Hgb
Omontys
peginesatide
red blood cell
red blood cell production

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014