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

June 1, 2021 updated by: Shire

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Drug: DYNEPO (epoetin delta)

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Stralsund, Germany
    - Hanse-Klinikum Stralsund
- Baden-Württemberg
  - Villingen - Schwenningen, Baden-Württemberg, Germany, 78054
    - Nephrologische Zentrum Villingen-Schwenningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with established Chronic Kidney Disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo Time Frame: 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.	up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2008

Primary Completion (Actual)

July 30, 2008

Study Completion (Actual)

July 30, 2008

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria