Clinical trial NCT01997892: TRANSFORM - Observational Cohort Study of Darbepoetin Alfa Use in European Union (EU) Hemodialysis Patients Switched From PEG Epoetin Beta
Official title: TRANSFORM - Observational Cohort Study of Aranesp Use in EU Haemodialysis Patients Switched From Mircera
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Keywords: CKD
Darbepoetin Alfa
Dialysis
Hemodialysis
Anemia
Peg epoetin beta
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-11-28
Enrollment: 1027
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD dialysed patients from EU centers treated with PEG epoetin beta for a minimum of 14weeks prior to switching to darbepoetin alfa.

Brief 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).

Detailed description: This is a multi-centre, observational cohort study of EU hemodialysis patients whose erythropoiesis stimulating agent (ESA) therapy has been switched from PEG epoetin beta to darbepoetin alfa. Data will be collected for the period spanning 14 weeks prior to switch through to 26 weeks post-switch.

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.

Primary outcomes:
measure: Hemoglobin Concentration at Monthly Intervals
timeFrame: Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)
Secondary outcomes:
measure: PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch
timeFrame: Month -3, Month -2, Month -1
measure: Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period
timeFrame: Month 1, 2, 3, 4, 5 and 6
measure: Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa
timeFrame: Week -1 and Week 1
measure: Hemoglobin Concentration Rate of Change by Period
timeFrame: Thre months prior to switch and 6 months after the switch
measure: Percentage of Participants With Hemoglobin Excursions
timeFrame: Month -3, -2, -1, 1, 2, 3, 4, 5 and 6
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Research Site
city: Antony
country: France
facility: Research Site
city: Aurillac
country: France
facility: Research Site
city: Blois
country: France
facility: Research Site
city: Boulogne sur Mer
country: France
facility: Research Site
city: Béziers
country: France
facility: Research Site
city: Cahors
country: France
facility: Research Site
city: Essey lès Nancy
country: France
facility: Research Site
city: Grabels
country: France
facility: Research Site
city: La Roche sur Yon Cedex 9
country: France
facility: Research Site
city: La Réunion
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Metz
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Saint Nazaire
country: France
facility: Research Site
city: Saint Pierre
country: France
facility: Research Site
city: Saint Priest en Jarez
country: France
facility: Research Site
city: Saint-Denis de la Réunion
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Nordhorn
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Ribeira
country: Spain
facility: Research Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Galicia
city: Sion
country: Switzerland
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Adv Ther. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. Epub 2014 Nov 1.