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

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:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00664066
First received: April 21, 2008
Last updated: September 28, 2009
Last verified: September 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

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

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664066

Locations
Germany
Nephrologische Zentrum Villingen-Schwenningen
Villingen - Schwenningen, Baden-Württemberg, Germany, 78054
Hanse-Klinikum Stralsund
Stralsund, Germany
Sponsors and Collaborators
Shire Development LLC
Investigators
Principal Investigator: Thomas Ittel Hanse-Klinikum Stralsund
Principal Investigator: Helmut Reichel Nephrologische Zentrum Villingen-Schwenningen
  More Information

No publications provided

Responsible Party: Timothy Whitaker M.D., Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00664066     History of Changes
Other Study ID Numbers: SPD490-404
Study First Received: April 21, 2008
Results First Received: August 18, 2009
Last Updated: September 28, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
 Urologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013