Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

Completed · Phase 3

Conditions studied: Chronic Kidney Disease, Anemia

In brief

The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.

Key facts

Study ID

NCT01478971

Run by

Takeda

People needed

184

Starts

2011-10-01

Expected to finish

2013-02-01

Last updated by the study team

2016-09-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have provided written informed consent in accordance with institutional, local, and national guidelines
• Are ≥18 years of age at the start of screening
• Have been on in-center hemodialysis for ≥12 weeks at the start of screening
• Are currently maintained on Epoetin at the start of screening
• If sexually active and a female of childbearing potential, are willing to use highly effective method of birth control ≥4 weeks before study enrollment and through the study
• If a female of childbearing potential, have a negative pregnancy test during screening

You may not qualify if…

• Are scheduled for a renal transplantation during study (Note: patients awaiting transplantation with no date scheduled may enroll.)
• Have an active malignancy or malignancy treated within one year prior to the start of screening for curative or palliative intent (Note: patients with non-melanoma skin cancers may enroll.)
• Have known intolerance to any ESA or PEGylated molecule
• Have been exposed to any investigational agent during the four weeks prior to the start of screening or are anticipated to receive such agents during the study
• Have any significant medical or psychiatric condition judged by the investigator to prevent informed consent or study compliance
• Are pregnant or nursing

Where it is running

• Research Facility — Sacramento, California, United States
• Research Facility — San Diego, California, United States
• Research Facility — San Jose, California, United States
• Research Facility — North Brunswick, New Jersey, United States
• Research Facility — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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