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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Collaborator: Affymax
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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