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Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.

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ClinicalTrials.gov Identifier: NCT00752609
Recruitment Status : Completed
First Posted : September 15, 2008
Results First Posted : July 27, 2012
Last Update Posted : July 27, 2012
Sponsor:
Collaborator:
Affymax
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to determine the efficacy and safety of Peginesatide Injection for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis or do not require dialysis and who were previously treated with Darbepoetin Alfa.

Condition or disease Intervention/treatment Phase
Anemia Drug: Peginesatide Phase 2

Detailed Description:

Anemia, resulting primarily from insufficient production of erythropoietin to support erythropoiesis, is a common consequence of chronic renal failure. Both North America and Europe have established clinical practice guidelines for the treatment and hemoglobin targets in chronic renal failure/chronic kidney disease patients. These guidelines recommend the use of erythropoiesis-stimulating agents (ESAs). The benefits of ESA therapy include reduced fatigue, improved quality of life, decreased cardiovascular mortality risk and improved cardiovascular function. An increased risk of death and serious cardiovascular and thromboembolic events, including myocardial infarction, stroke, congestive heart failure, and hemodialysis graft occlusion have been observed in controlled clinical trials of ESAs when administered to target hemoglobin levels of ≥13.5 g/dL. The vast majority of patients receiving hemodialysis receive ESA therapy to treat their anemia and most patients begin ESA therapy prior to any requirement for dialysis.

Anemia of chronic renal failure is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors also include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anemia increases with progressive deterioration of renal function, and affects more than 90% of patients with chronic renal failure Stage 5 (End Stage Renal Disease). Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, increased left ventricular hypertrophy and heart failure. Treatment of anemia reduces morbidity and mortality risks and may improve quality of life.

Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure participants, and have improved the management of anemia over alternatives such as transfusion. Peginesatide (hematide) is a parenteral formulation being developed for the correction of anemia in patients with chronic renal failure, and 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.

Participants in this study received variable doses of peginesatide injection once every four weeks. Total commitment time for this study was about 30 weeks.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of the Safety and Efficacy of Hematide Injection for the Maintenance Treatment of Anemia in Subjects With Chronic Renal Failure Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa
Study Start Date : September 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Peginesatide Drug: Peginesatide
Peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
Other Names:
  • Hematide
  • AF37702
  • Omontys



Primary Outcome Measures :
  1. Mean Change in Hemoglobin Between Baseline and the Evaluation Period [ Time Frame: Baseline and Week 19 to Week 24. ]
    Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24).


Secondary Outcome Measures :
  1. Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period [ Time Frame: Week 19 to Week 24 ]

    Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL.

    The 95% confidence interval was calculated from the normal approximation with continuity correction.


  2. Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL [ Time Frame: Baseline and Week 19 to Week 24. ]

    Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL.

    The 95% confidence interval was calculated from the normal approximation with continuity correction.


  3. Percentage of Participants With Red Blood Cell Transfusions [ Time Frame: Up to 24 weeks. ]
    The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.

  4. Mean Hemoglobin During 4-week Intervals [ Time Frame: Up to 24 weeks. ]
    Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24).

  5. Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. [ Time Frame: Up to 24 weeks. ]
    Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.

  6. Percentage of Participants With Dose Adjustments During the Study [ Time Frame: From Week 4 to Week 20 ]
    The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient was a man or woman 18 to 90 years of age, inclusive.
  2. The patient had CKD and met 1 of the following criteria:

    1. Had been on dialysis for ≥6 months prior to enrollment, or
    2. Had not yet begun dialysis (hemodialysis or peritoneal dialysis) and was not anticipated to require initiation of dialysis during participation in the study.
  3. The patient was on stable darbepoetin alfa maintenance therapy (either SC or IV) continuously for a minimum of 8 weeks prior to enrollment.
  4. The patient had 4 consecutive Hb values with a mean ≥10.0 and ≤12.0 g/dL during screening period, with the difference between the mean of the first 2 consecutive Hb values and the mean of the last 2 consecutive values being ≤1.0 g/dL.

Exclusion Criteria:

  1. The patient had known bleeding or coagulation disorder.
  2. The patient had known hematologic disease or cause of anemia other than renal disease (i.e., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiplemyeloma, hemolytic anemia, and myelodysplastic syndrome).
  3. The patient had received a recent course of intensive iron replacement (i.e., more than 500 mg IV in the 28 days prior to enrollment).
  4. The patient had advanced chronic CKD defined by New York Heart Association Class III or IV.
  5. The patient had a known history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrollment.
  6. The patient had a scheduled kidney transplant. Patients currently on a transplant waiting list were not excluded, unless there was an identified donor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752609


Locations
United States, California
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
United States, Connecticut
Middlebury, Connecticut, United States
United States, Florida
Lauderdale Lakes, Florida, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Michigan
Dearborn, Michigan, United States
United States, Mississippi
Columbus, Mississippi, United States
United States, New York
Mineola, New York, United States
United States, Texas
Arlington, Texas, United States
Sponsors and Collaborators
Takeda
Affymax
Investigators
Study Director: Medical Director Takeda

Additional Information:
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00752609     History of Changes
Other Study ID Numbers: AFX01_202
2008-003459-64 ( EudraCT Number )
U1111-1114-1500 ( Registry Identifier: WHO )
First Posted: September 15, 2008    Key Record Dates
Results First Posted: July 27, 2012
Last Update Posted: July 27, 2012
Last Verified: June 2012

Keywords provided by Takeda:
Anemia
Drug Therapy
Hemodialysis
Kidney Failure

Additional relevant MeSH terms:
Anemia
Renal Insufficiency
Kidney Failure, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Darbepoetin alfa
Hematinics