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

Anemia Clinical Trial

— DELFT  

Official title:

A Non-Interventional, Post-Authorisation Study to Assess Adverse Events and Drug Utilisation Among Chronic Kidney Disease Patients Treated With DYNEPO

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00664066
• Other study ID #: SPD490-404
• Status: Terminated
• Start date: April 25, 2008
• Est. completion date: July 30, 2008

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 30, 2008
• Est. primary completion date: July 30, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Germany	Hanse-Klinikum Stralsund	Stralsund
Germany	Nephrologische Zentrum Villingen-Schwenningen	Villingen - Schwenningen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo	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.	up to 3 years