Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.

Completed · Phase 2

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT00752791

Run by

Takeda

People needed

59

Starts

2008-10-01

Expected to finish

2010-05-01

Last updated by the study team

2012-08-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Study site — Azusa, California, United States
• Study site — Los Angeles, California, United States
• Study site — Whittier, California, United States
• Study site — Naples, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Evergreen Park, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — New Iberia, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Columbus, Mississippi, United States
• Study site — Tupelo, Mississippi, United States
• Study site — New York, New York, United States
• Study site — Williamsville, New York, United States
• Study site — Canton, Ohio, United States
• Study site — Arlington, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Fairfax, Virginia, United States
• Study site — Mechanicsville, Virginia, United States
• Study site — New Lambtom, New South Wales, Australia
• Study site — Modena, Modena, Italy
• Study site — Dunedin, Dunedin, New Zealand
• Study site — London, England, United Kingdom

Full record on ClinicalTrials.gov

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