End Stage Renal DiseasePhase 4NCT00117104
Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis
A Phase 4 study testing Aranesp® in people with End Stage Renal Disease, run by Amgen.
Trial summary
The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy administered IV thrice weekly (TIW). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Aranesp®
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Inclusion Criteria: - Subjects with end stage renal disease (ESRD) on hemodialysis Exclusion Criteria: - Known hypersensitivity to Aranesp® (darbepoetin alfa) or any of its excipients - Participating in an investigational drug or device trial - Patient will not be available for follow-up assessment - Patient has any disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures
About this study
Official title: A Multicenter Study Evaluating Once Weekly Intravenous Administration of Aranesp® in Subjects With End Stage Renal Disease on Chronic Hemodialysis
The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy administered IV thrice weekly (TIW).
- Conditions
- End Stage Renal Disease
- Being tested
- Aranesp®
- Keywords
- End Stage Renal Disease (ESRD), Kidney Disease, Dialysis, Aranesp®, rHuEPO, Anemia, Hemoglobin, Dosing, Amgen
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aranesp®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Target hemoglobin (Hgb)
Secondary outcomes (1)
Distribution of hemoglobin (Hgb) values by week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117104
- Sponsor's protocol ID
- 20030133
- Status last verified
- Oct 2009
- First submitted
- 30 Jun 2005
- Last updated
- 16 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study Evaluating Once Weekly Intravenous Administration of Aranesp® in Subjects With End Stage Renal Disease on Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT00117104
- Acronym / sponsor ID
- 20030133
- Conditions
- End Stage Renal Disease
- Keywords
- End Stage Renal Disease (ESRD), Kidney Disease, Dialysis, Aranesp®, rHuEPO, Anemia, Hemoglobin, Dosing, Amgen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- First posted
- 4 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy administered IV thrice weekly (TIW).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Aranesp® | Drug | – |
Primary outcome
Target hemoglobin (Hgb)
1 secondary outcome
Distribution of hemoglobin (Hgb) values by week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2009.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aranesp® in people with End Stage Renal Disease, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 16 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Target hemoglobin (Hgb). 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 16 Oct 2009.