AnemiaDELFTNCT00664066
DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)
An observational study of Anemia and Kidney Diseases, run by Shire at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia, Kidney Diseases, Renal Failure, Chronic
- What is being tested?
- DYNEPO (epoetin delta)
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 2 sitesGermany
- Study dates
- 25 Apr 2008to 30 Jul 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with established Chronic Kidney Disease
Who may be able to join
- 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.
Who cannot join
- Known intolerance to EPO of any of its excipients
- Known of suspected Pure Red Cell Aplasia (PRCA)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Hanse-Klinikum Stralsund
Stralsund
Nephrologische Zentrum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg, 78054
About this study
Official title: 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.
- Being tested
- DYNEPO (epoetin delta)
- Medical subject headings
- Anemia, Kidney Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study start25 Apr 2008
- Primary completion30 Jul 2008
- Study completion30 Jul 2008
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664066
- Sponsor's protocol ID
- SPD490-404
- Acronym
- DELFT
- Status last verified
- May 2021
- First submitted
- 21 Apr 2008
- Last updated
- 25 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional, Post-Authorisation Study to Assess Adverse Events and Drug Utilisation Among Chronic Kidney Disease Patients Treated With DYNEPO
- ClinicalTrials.gov ID
- NCT00664066
- Acronym / sponsor ID
- DELFT / SPD490-404
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2008 (actual)
- Primary completion
- 30 Jul 2008 (actual)
- Study completion
- 30 Jul 2008 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 28 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with established Chronic Kidney Disease
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Known intolerance to EPO of any of its excipients
- Known of suspected Pure Red Cell Aplasia (PRCA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | – |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Kidney Diseases, run by Shire at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.