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

NCT ID: NCT01997892

Last Updated: 2014-06-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1027 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Edegem, , Belgium

Site Status

Research Site

Antony, , France

Site Status

Research Site

Aurillac, , France

Site Status

Research Site

Béziers, , France

Site Status

Research Site

Blois, , France

Site Status

Research Site

Boulogne-sur-Mer, , France

Site Status

Research Site

Cahors, , France

Site Status

Research Site

Essey-lès-Nancy, , France

Site Status

Research Site

Grabels, , France

Site Status

Research Site

La Réunion, , France

Site Status

Research Site

La Roche-sur-Yon, , France

Site Status

Research Site

Libourne, , France

Site Status

Research Site

Lille, , France

Site Status

Research Site

Metz, , France

Site Status

Research Site

Paris, , France

Site Status

Research Site

Paris, , France

Site Status

Research Site

Poitiers, , France

Site Status

Research Site

Saint-Denis de La Réunion, , France

Site Status

Research Site

Saint-Nazaire, , France

Site Status

Research Site

Saint-Pierre, , France

Site Status

Research Site

Saint-Priest-en-Jarez, , France

Site Status

Research Site

Strasbourg, , France

Site Status

Research Site

Vandœuvre-lès-Nancy, , France

Site Status

Research Site

Kiel, , Germany

Site Status

Research Site

Nordhorn, , Germany

Site Status

Research Site

Athens, , Greece

Site Status

Research Site

Athens, , Greece

Site Status

Research Site

Arnhem, , Netherlands

Site Status

Research Site

Ribeira, Galicia, Spain

Site Status

Research Site

Santiago de Compostela, Galicia, Spain

Site Status

Research Site

Santiago de Compostela, Galicia, Spain

Site Status

Research Site

Sion, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium France Germany Greece Netherlands Spain Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25367412 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20120126

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.