AnemiaPhase 4NCT00514813

Dynepo Long-Term Safety Study

A Phase 4 study testing Dynepo in people with Anemia and Kidney Failure, Chronic, run by Shire at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia, Kidney Failure, Chronic
What is being tested?: Dynepo
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 1 siteBelgium
Study dates: 6 Jun 2007to 31 Jul 2008
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who complete Dynepo study SPD490-301.
Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301.

Who cannot join

Withdrawal, before Week 24, from study SPD490-301.
Pregnant or lactating women.
Uncontrolled hypertension.
Thrombocytopenia (platelet count <75,000/mm3).
Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).
Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study.

Show all 10Show fewer

Androgen therapy in the 30 days immediately prior to enrolment in this study.
Known Human Immunodeficiency Virus (HIV) infection.
History of hypersensitivity to Dynepo.
Known to have Ab against EPO.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Heilig Hartziekenhuis Department of Nephrology
Lier

Other trials in Belgium

About this study

Official title: An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease

To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.

Conditions: Anemia, Kidney Failure, Chronic
Being tested: Dynepo
Medical subject headings: Anemia, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DynepoDrug
Also called Epoetin delta
Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject

Study groups in NCT00514813
Study group	Role	What they receive
Dynepo (Epoetin delta)	Experimental	Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject Receives: Drug: Dynepo

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)
Measured: Over the course of 2 Years

Secondary outcomes (2)

Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years
Measured: Baseline and 2 years
Change From Baseline in Hematocrits at 2 Years
Measured: Baseline and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 200731 Jul 2008

First posted10 Aug 2007 (estimated)
Study start6 Jun 2007
Primary completion31 Jul 2008
Study completion31 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: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00514813
Sponsor's protocol ID: SPD490-402
Other IDs: 2007-000054-31
Status last verified: Jun 2021
First submitted: 9 Aug 2007
Last updated: 13 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT00514813
Acronym / sponsor ID: SPD490-402
Conditions: Anemia, Kidney Failure, Chronic
Phase: Phase 4
Study type: Interventional
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: 152 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 6 Jun 2007 (actual)
Primary completion: 31 Jul 2008 (actual)
Study completion: 31 Jul 2008 (actual)
First posted: 10 Aug 2007 (estimated)
Results: Posted 9 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dynepo (Epoetin delta)	Experimental	Drug: DynepoSubjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients who complete Dynepo study SPD490-301.
Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301.

Key exclusion criteria (10 listed)

Withdrawal, before Week 24, from study SPD490-301.
Pregnant or lactating women.
Uncontrolled hypertension.
Thrombocytopenia (platelet count <75,000/mm3).
Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).

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
DynepoAlso: Epoetin deltaSubcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject	Drug	Dynepo (Epoetin delta)

Primary outcome

Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Over the course of 2 Years

2 secondary outcomes

Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years
Time frame: Baseline and 2 years
Change From Baseline in Hematocrits at 2 Years
Time frame: Baseline and 2 years

Results and safety

Results posted to the registry on 9 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dynepo (Epoetin Delta) Twice Weekly (BIW)	15	0
Dynepo Once Weekly (QW)	86	0
Dynepo Once Every 2 Weeks (Q2W)	47	0
Dynepo Once Every 4 Weeks (Q4W)	4	0

Primary outcome: Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)

Time frame: Over the course of 2 Years

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dynepo (Epoetin Delta) Twice Weekly (BIW)	1 of 15 (6.7%)	7 of 15 (46.7%)	Not reported
Dynepo Once Weekly (QW)	14 of 84 (16.7%)	62 of 84 (73.8%)	Not reported
Dynepo Once Every 2 Weeks (Q2W)	6 of 47 (12.8%)	32 of 47 (68.1%)	Not reported
Dynepo Once Every 4 Weeks (Q4W)	1 of 4 (25%)	4 of 4 (100%)	Not reported

Limitations and caveats (from the sponsor): This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dynepo in people with Anemia and Kidney Failure, Chronic, run by Shire at 1 site in Belgium.

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 2 inclusion and 10 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 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 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?

Rate of Emergence of Treatment Emergent Adverse Events (TEAEs) (time frame: Over the course of 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00514813.

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 13 Jul 2021.