DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)
Terminated
- Conditions
- AnemiaKidney Failure, ChronicKidney DiseasesRenal Failure, Chronic
- Registration Number
- NCT00664066
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hanse-Klinikum Stralsund
🇩🇪Stralsund, Germany
Nephrologische Zentrum Villingen-Schwenningen
🇩🇪Villingen - Schwenningen, Baden-Württemberg, Germany