Status:
COMPLETED
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
Lead Sponsor:
Takeda
Collaborating Sponsors:
Affymax
Conditions:
Chronic Kidney Disease
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Monthly Erythropoiesis-Stimulating Agents (ESA) dosing, compared with the longstanding practice of dosing three times per week, represents a significant change in anemia treatment for dialysis patient...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT01478971
Start Date
October 1 2011
End Date
February 1 2013
Last Update
September 20 2016
Active Locations (5)
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1
Research Facility
Sacramento, California, United States, 95825
2
Research Facility
San Diego, California, United States, 91910
3
Research Facility
San Jose, California, United States, 95128
4
Research Facility
North Brunswick, New Jersey, United States, 08902