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NCT01997892 Clinical Trial

TRANSFORM - Observational Cohort Study of Darbepoetin Alfa Use in European Union (EU) Hemodialysis Patients Switched From PEG Epoetin Beta

Anemia Clinical Trial

— TRANSFORM  

Official title:
TRANSFORM - Observational Cohort Study of Aranesp Use in EU Haemodialysis Patients Switched From Mircera

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01997892
Other study ID # 20120126
Secondary ID
Status Completed
Phase N/A
First received December 18, 2012
Last updated June 3, 2014
Start date August 2012
Est. completion date July 2013

Study information
Verified date June 2014
Source Amgen
Contact n/a
Is FDA regulated No
Health authority Spain: Regional Competent AuthorityGermany: Federal Institute for Drugs and Medical DevicesFrance: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéBelgium: Federal Agency for Medicinal Products and Health ProductsNetherlands: Medical Ethics Review Committee (METC)Poland: Ethics Committee
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 1027
Est. completion date July 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Research Site Edegem
France Research Site Antony
France Research Site Aurillac
France Research Site Béziers
France Research Site Blois
France Research Site Boulogne sur Mer
France Research Site Cahors
France Research Site Essey lès Nancy
France Research Site Grabels
France Research Site La Réunion
France Research Site La Roche sur Yon Cedex 9
France Research Site Libourne
France Research Site Lille Cedex
France Research Site Metz
France Research Site Paris
France Research Site Paris
France Research Site Poitiers
France Research Site Saint Nazaire
France Research Site Saint Pierre
France Research Site Saint Priest en Jarez
France Research Site Saint-Denis de la Réunion
France Research Site Strasbourg
France Research Site Vandoeuvre Les Nancy Cedex
Germany Research Site Kiel
Germany Research Site Nordhorn
Greece Research Site Athens
Greece Research Site Athens
Netherlands Research Site Arnhem
Spain Research Site Ribeira Galicia
Spain Research Site Santiago de Compostela Galicia
Spain Research Site Santiago de Compostela Galicia
Switzerland Research Site Sion

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Greece,  Netherlands,  Spain,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin Concentration at Monthly Intervals Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period. Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch) No
Secondary PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 µg have been excluded as they were deemed infeasible values derived by the algorithm. Month -3, Month -2, Month -1 No
Secondary Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 µg have been excluded as they were deemed infeasible values derived by the algorithm. Month 1, 2, 3, 4, 5 and 6 No
Secondary Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa Dose ratio is the average weekly dose of the first darbepoetin alfa dose divided by the average weekly dose of peg-epoetin beta at switch (µg darbepoetin alfa per 1 µg pegylated-epoetin beta). Week -1 and Week 1 No
Secondary Hemoglobin Concentration Rate of Change by Period The hemoglobin rate of change is the maximum monthly increase and maximum monthly decrease for the pre- and post-switch periods. Within each period, the difference was calculated between each hemoglobin value and the most recent hemoglobin value taken at least 28 days previously. The rate of change was calculated by dividing this difference by the number of days in the interval and multiplying by 28. The maximum and minimum rate of change was then determined per participant. Thre months prior to switch and 6 months after the switch No
Secondary Percentage of Participants With Hemoglobin Excursions The percentage of participants with at least one hemoglobin excursion, defined as hemoglobin concentrations below 10.0 g/dL and above 12.0 g/dL during the pre- and post-switch periods. Month -3, -2, -1, 1, 2, 3, 4, 5 and 6 No
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