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

This study has been 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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664066
First Posted: April 22, 2008
Last Update Posted: September 30, 2009
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.
Information provided by:
Shire
  Purpose
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 Intervention
Anemia Kidney Diseases Renal Failure, Chronic Kidney Failure, Chronic Drug: DYNEPO (epoetin delta)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo [ Time Frame: up to 3 years ]

Enrollment: 3
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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)
  Contacts and Locations
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
Germany
Nephrologische Zentrum Villingen-Schwenningen
Villingen - Schwenningen, Baden-Württemberg, Germany, 78054
Hanse-Klinikum Stralsund
Stralsund, Germany
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Thomas Ittel Hanse-Klinikum Stralsund
Principal Investigator: Helmut Reichel Nephrologische Zentrum Villingen-Schwenningen
  More Information

Responsible Party: Timothy Whitaker M.D., Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00664066     History of Changes
Other Study ID Numbers: SPD490-404
First Submitted: April 21, 2008
First Posted: April 22, 2008
Results First Submitted: August 18, 2009
Results First Posted: September 28, 2009
Last Update Posted: September 30, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Epoetin Alfa
Hematinics


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