Phase 3
Completed N=184
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
Source: ClinicalTrials.gov NCT01478971 ↗Enrolled (actual)
184
Serious AEs
24.2%
Results posted
May 2014
Primary outcomePrimary: Percentage of Participants Undergoing Conversion to Peginesatide Injection — 88 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Undergoing Conversion to Peginesatide Injection |
88 | — |
| SECONDARY Peginesatide Dosing |
5.1; 4.9; 5.2 | — |
| SECONDARY Peginesatide Dose Deviations |
— | — |
| SECONDARY Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL |
39.1; 44.5; 40.8; 46.5; 41.0; 45.2 | — |
| SECONDARY Percentage of Participants Who Received at Least One Intravenous Iron Dose |
85.4; 73.2 | — |
| SECONDARY Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion |
10.7; 8.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01478971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.