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

Shire3 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anemia Kidney Diseases Renal Failure, Chronic Kidney Failure, Chronic

Interventions

DYNEPO (epoetin delta)DRUG

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

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (2)

Nephrologische Zentrum Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Hanse-Klinikum Stralsund

Stralsund, Germany

Outcomes

Primary Outcomes

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.

Time frame: up to 3 years

Data from ClinicalTrials.gov

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