N/A
N=1,027
TRANSFORM - Observational Cohort Study of Darbepoetin Alfa Use in European Union (EU) Hemodialysis Patients Switched From PEG Epoetin Beta
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01997892 ↗Enrolled (actual)
1,027
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Hemoglobin Concentration at Monthly Intervals — 11.27; 11.26; 11.19; 11.14 g/dL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin Concentration at Monthly Intervals |
11.27; 11.26; 11.19; 11.14; 11.36; 11.48 | — |
| SECONDARY PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch |
27.7; 26.5; 27.4 | — |
| SECONDARY Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period |
29.4; 27.8; 25.4; 23.3; 23.8; 25.6 | — |
| SECONDARY Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa |
1.06 | — |
| SECONDARY Hemoglobin Concentration Rate of Change by Period |
0.64; 1.17; -0.73; -1.21 | — |
| SECONDARY Percentage of Participants With Hemoglobin Excursions |
16.8; 29.0; 17.7; 29.0; 15.7; 24.8 | — |
Summary
To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).
Eligibility Criteria
Inclusion Criteria
- Patients >18 years of age. CKD diagnosis, receiving hemodialysis
- Received PEG epoetin beta for 14weeks prior to switching to darbepoetin alfa and received at least one dose of darbepoetin alfa.
Data sourced from ClinicalTrials.gov (NCT01997892). 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.