Kidney DiseasePhase 3NCT00116701
Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
A Phase 3 study testing Aranesp® in people with Kidney Disease, run by Amgen.
Trial summary
Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease
- What is being tested?
- Aranesp®
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2005to not given
- Phase
- Phase 3
- 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: -at least 18 years old - Diagnosis of chronic kidney disease (CKD) and receiving dialysis for at least 3 months prior to screening - Baseline Hb level greater than or equal to 10.0 g/dL and less than or equal to 13.0 g/dL - Adequate iron stores (defined as serum ferritin greater than or equal to 100 µg/L or transferrin saturation [TSAT] greater than or equal to 20%) - Stable IV (epoetin alfa or beta) or SC rHuEPO (epoetin beta) therapy 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than 25% change in weekly dose and no change in frequency or route) - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. Exclusion Criteria: - Received SC epoetin alfa in the 12 months before screening - Uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg or systolic blood pressure greater than 180 mmHg on 2 separate occasions during screening) - Prior history (within 12 weeks before enrolment) of cardiovascular events including:
- acute myocardial ischemia;
- hospitalization for congestive heart failure;
- myocardial infarction. - Pregnant or breast-feeding women - Treatment with an investigational agent or device within 30 days before screening or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study - Known sensitivity to any of the products to be administered during dosing - Disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
About this study
Official title: A Study to Evaluate the Efficacy of Converting From Intravenous or Subcutaneous rHuEPO to Intravenous Darbepoetin Alfa (Aranesp®) in Subjects With Chronic Kidney Disease Receiving Haemodialysis
Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL.
Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at > 11 g/dL.
- Conditions
- Kidney Disease
- Being tested
- Aranesp®
- Keywords
- Chronic Kidney Disease (CKD), Haemoglobin (Hb), Erthropoetin (EPO), End Stage Renal Disease (ESRD), Recombinant Human Erthropoetic (rHuEPO), Anaemia, Darbepoetin Alfa, Aranesp®, Haemodialysis, Clinical Trial
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Kidney Failure, Chronic, 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.
Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)
Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)
Secondary outcomes (7)
Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2
Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL
Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2
Treatment period 2: Dose and frequency of darbepoetin alfa administration over the treatment period
Treatment period 1:The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period
Treatment period 1: Change in Hb between screening/baseline and the evaluation period
Treatment period 1: Dose and frequency of darbepoetin alfa administration over the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2005 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116701
- Sponsor's protocol ID
- 20040218
- Status last verified
- May 2008
- First submitted
- 30 Jun 2005
- Last updated
- 5 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Converting From Intravenous or Subcutaneous rHuEPO to Intravenous Darbepoetin Alfa (Aranesp®) in Subjects With Chronic Kidney Disease Receiving Haemodialysis
- ClinicalTrials.gov ID
- NCT00116701
- Acronym / sponsor ID
- 20040218
- Conditions
- Kidney Disease
- Keywords
- Chronic Kidney Disease (CKD), Haemoglobin (Hb), Erthropoetin (EPO), End Stage Renal Disease (ESRD), Recombinant Human Erthropoetic (rHuEPO), Anaemia, Darbepoetin Alfa, Aranesp®, Haemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2005
- First posted
- 1 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.
Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL.
Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at > 11 g/dL.
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
Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)
Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)
7 secondary outcomes
Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2
Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL
Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2
Treatment period 2: Dose and frequency of darbepoetin alfa administration over the treatment period
Treatment period 1:The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period
Treatment period 1: Change in Hb between screening/baseline and the evaluation period
Treatment period 1: Dose and frequency of darbepoetin alfa administration over the treatment period
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 5 May 2008.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink 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 3 study testing Aranesp® in people with Kidney 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 5 May 2008. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24). The study lists 2 primary outcomes in all. 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 5 May 2008.