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

June 3, 2014 updated by: Amgen

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

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1027

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Research Site
  • France
      • Antony, France, 92160
        • Research Site
      • Aurillac, France, 15000
        • Research Site
      • Blois, France, 41000
        • Research Site
      • Boulogne sur Mer, France, 62200
        • Research Site
      • Béziers, France, 34500
        • Research Site
      • Cahors, France, 46000
        • Research Site
      • Essey lès Nancy, France, 54270
        • Research Site
      • Grabels, France, 34790
        • Research Site
      • La Roche sur Yon Cedex 9, France, 85925
        • Research Site
      • La Réunion, France, 97420
        • Research Site
      • Libourne, France, 33505
        • Research Site
      • Lille Cedex, France, 59800
        • Research Site
      • Metz, France, 57000
        • Research Site
      • Paris, France, 75015
        • Research Site
      • Paris, France, 75016
        • Research Site
      • Poitiers, France, 86021
        • Research Site
      • Saint Nazaire, France, 44606
        • Research Site
      • Saint Pierre, France, 97410
        • Research Site
      • Saint Priest en Jarez, France, 42270
        • Research Site
      • Saint-Denis de la Réunion, France, 97400
        • Research Site
      • Strasbourg, France, 67000
        • Research Site
      • Vandoeuvre Les Nancy Cedex, France, 54504
        • Research Site
  • Germany
      • Kiel, Germany, 24106
        • Research Site
      • Nordhorn, Germany, 48527
        • Research Site
  • Greece
      • Athens, Greece, 11528
        • Research Site
      • Athens, Greece, 15562
        • Research Site
  • Netherlands
      • Arnhem, Netherlands, 6815 AD
        • Research Site
  • Spain
    • Galicia
      • Ribeira, Galicia, Spain, 15993
        • Research Site
      • Santiago de Compostela, Galicia, Spain, 15706
        • Research Site
      • Santiago de Compostela, Galicia, Spain, 15701
        • Research Site
  • Switzerland
      • Sion, Switzerland, 1950
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic Kidney Disease (CKD)
Participants with CKD on dialysis and treated with PEG epoetin beta for a minimum of 14 weeks immediately prior to being switched to darbepoetin alfa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Concentration at Monthly Intervals
Time Frame: Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch
Time Frame: Month -3, Month -2, Month -1
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
Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period
Time Frame: Month 1, 2, 3, 4, 5 and 6
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
Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa
Time Frame: Week -1 and Week 1
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
Hemoglobin Concentration Rate of Change by Period
Time Frame: Thre months prior to switch and 6 months after the switch
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
Percentage of Participants With Hemoglobin Excursions
Time Frame: Month -3, -2, -1, 1, 2, 3, 4, 5 and 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

November 25, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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