Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00680043
First received: May 15, 2008
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.


Condition Intervention Phase
Anemia
Chronic Renal Failure
Chronic Kidney Disease
Drug: peginesatide
Drug: Epoetin Alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AFX01-15: A Phase 2, 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) Undergoing Hemodialysis 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 21-28 ] [ Designated as safety issue: No ]
    The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28.


Secondary Outcome Measures:
  • Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods [ Time Frame: Weeks 1 to 28 ] [ Designated as safety issue: No ]
  • Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods [ Time Frame: Weeks 1 to 28 ] [ Designated as safety issue: No ]
    A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks.


Enrollment: 114
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peginesatide 0.04 mg/kg Drug: peginesatide
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose 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 0.08 mg/kg Drug: peginesatide
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose 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: Epoetin Alfa Drug: Epoetin Alfa
Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Other Name: Eprex

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 equal proportions to two peginesatide treatment regimens, in which participants received peginesatide once every 4 weeks, and one control, epoetin alfa, treatment regimen, in which participants received epoetin alfa three times per week. Total commitment time of this study was a 4 week screening period followed by a minimum of 7 months of treatment.

  Eligibility

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

Inclusion Criteria

  1. On hemodialysis for chronic renal failure for at least 2 weeks prior to randomization.
  2. Two consecutive hemoglobin values of ≥ 8.0 g/dL and < 11.0 g/dL within the 4 weeks prior to randomization.

Exclusion Criteria

  1. Females who are pregnant or breast-feeding.
  2. Prior treatment with an erythropoiesis stimulating agent (ESA) in the 12 weeks prior to randomization.
  3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
  4. Known bleeding or coagulation disorder.
  5. Known hematologic disease or cause for anemia other than renal disease
  6. Poorly controlled hypertension.
  7. Evidence of active malignancy within one year.
  8. 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: NCT00680043

Locations
Russian Federation
Research Facility
Irkutsk, Russian Federation
Research Facility
Krasnodar, Russian Federation
Research Facility
Krasnoyarsk, Russian Federation
Research Facility
Moscow, Russian Federation
Research Facility
Nizhniy Novgorod, Russian Federation
Research Facility
Omsk, Russian Federation
Research Facility
Petrozavodsk, Russian Federation
Research Facility
Saratov, Russian Federation
Research Facility
St. Petersburg, Russian Federation
Research Facility
Tver, Russian Federation
Research Facility
Volzhsk, Russian Federation
Sponsors and Collaborators
Affymax
Takeda
Investigators
Study Director: Vice President, Clinical Development Affymax
  More Information

No publications provided

Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00680043     History of Changes
Other Study ID Numbers: AFX01-15
Study First Received: May 15, 2008
Results First Received: April 26, 2012
Last Updated: June 22, 2012
Health Authority: United States: Food and Drug Administration
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation

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
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014