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Completed

NCT Number: NCT01997892

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Edegem, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Acronym: TRANSFORM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2013
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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