Status:
COMPLETED
Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.
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 maintenance treatment of anemia in participants on peritoneal dialysis.
Detailed Description
According to the International Federation of Renal Registries, in 1999 the prevalence of peritoneal dialysis in the United States as approximately 9.5% of patients receiving dialysis (2005 United Stat...
Eligibility Criteria
Inclusion
- The patient was a man or woman and 18 to 90 years of age, inclusive.
- The patient had CKD and had been on peritoneal dialysis for ≥3 months before enrollment.
- The patient was on stable SC epoetin (alfa or beta) maintenance therapy continuously prescribed 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 the screening period, with the difference between the mean of the first confirmed (2 consecutive) Hb values and the mean of the last confirmed (2 consecutive) Hb values being ≤1.0 g/dL.
- The patient had 1 ferritin level ≥100 ng/mL within 4 weeks before enrollment.
Exclusion
- The patient had known bleeding or coagulation disorder.
- The patient had known hematologic disease or cause of anemia other than renal disease (e.g., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiple myeloma, 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 before enrollment).
- The patient had advanced chronic congestive heart failure 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 before enrollment.
- The patient had a scheduled kidney transplant. (Note: patients who were currently on a transplant waiting list were not excluded unless there was an identified donor).
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00752791
Start Date
October 1 2008
End Date
May 1 2010
Last Update
August 15 2012
Active Locations (23)
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1
Azusa, California, United States
2
Los Angeles, California, United States
3
Whittier, California, United States
4
Naples, Florida, United States