Status:
COMPLETED
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.
Lead Sponsor:
Takeda
Collaborating Sponsors:
Affymax
Conditions:
Anemia
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 requi...
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 c...
Eligibility Criteria
Inclusion
- The patient was a man or woman 18 to 90 years of age, inclusive.
- The patient had CKD and met 1 of the following criteria:
- Had been on dialysis for ≥6 months prior to enrollment, or
- Had not yet begun dialysis (hemodialysis or peritoneal dialysis) and was not anticipated to require initiation of dialysis during participation in the study.
- The patient was on stable darbepoetin alfa maintenance therapy (either SC or IV) continuously for a minimum of 8 weeks prior to enrollment.
- 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
- The patient had known bleeding or coagulation disorder.
- 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).
- 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).
- The patient had advanced chronic CKD defined by New York Heart Association Class III or IV.
- The patient had a known history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrollment.
- The patient had a scheduled kidney transplant. Patients currently on a transplant waiting list were not excluded, unless there was an identified donor.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00752609
Start Date
September 1 2008
End Date
December 1 2009
Last Update
July 27 2012
Active Locations (10)
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1
Los Angeles, California, United States
2
Sacramento, California, United States
3
San Diego, California, United States
4
Middlebury, Connecticut, United States