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DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment) (DELFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00664066
Recruitment Status : Terminated (The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA)
First Posted : April 22, 2008
Results First Posted : September 28, 2009
Last Update Posted : September 30, 2009
Sponsor:
Information provided by:
Shire

Brief Summary:
This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect & describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.

Condition or disease Intervention/treatment
Anemia Kidney Diseases Renal Failure, Chronic Kidney Failure, Chronic Drug: DYNEPO (epoetin delta)

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional, Post-Authorisation Study to Assess Adverse Events and Drug Utilisation Among Chronic Kidney Disease Patients Treated With DYNEPO
Study Start Date : April 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: DYNEPO (epoetin delta)
    dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits, as this is an observational study


Primary Outcome Measures :
  1. Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo [ Time Frame: up to 3 years ]
    This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with established Chronic Kidney Disease
Criteria

Inclusion Criteria:

  • Adult patients must have established Chronic Kidney Disease (CKD) and be willing and able to provide written informed consent.
  • Patients must already be receiving DYNEPO treatment at time of study entry.
  • Patients who are likely to receive DYNEPO for at least 1 year.

Exclusion Criteria:

  • Known intolerance to EPO of any of its excipients
  • Known of suspected Pure Red Cell Aplasia (PRCA)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664066


Locations
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Germany
Nephrologische Zentrum Villingen-Schwenningen
Villingen - Schwenningen, Baden-Württemberg, Germany, 78054
Hanse-Klinikum Stralsund
Stralsund, Germany
Sponsors and Collaborators
Shire
Investigators
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Principal Investigator: Thomas Ittel Hanse-Klinikum Stralsund
Principal Investigator: Helmut Reichel Nephrologische Zentrum Villingen-Schwenningen
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Responsible Party: Timothy Whitaker M.D., Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00664066    
Other Study ID Numbers: SPD490-404
First Posted: April 22, 2008    Key Record Dates
Results First Posted: September 28, 2009
Last Update Posted: September 30, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Epoetin Alfa
Hematinics