Kidney DiseasePhase 3NCT00124098
An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD)
A Phase 3 study testing Aranesp® (darbepoetin alfa) in people with Kidney Disease, run by Amgen.
Trial summary
The purpose of this study is to assess if Aranesp® administered once every 4 weeks to chronic kidney disease subjects is safe and efficacious in maintaining haemoglobin levels greater than or equal to 100 g/L. 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® (darbepoetin alfa)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento 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
Who may be able to join
- Diagnosis of chronic kidney disease and not expected to initiate dialysis for the duration of the study
- Creatinine clearance greater than 15 and less than 40 mL/min as estimated by the Cockroft-Gault equation:
- Creatinine Clearance = (140-age in years) x body weight in kg/serum creatinine (mg/dL) x 72.
- For women, the value will be multiplied by 0.85
- Receiving stable every other week subcutaneous doses of Aranesp®.
- A stable dose is defined as less than or equal to 25% change in Aranesp® dose over the 6-week period immediately prior to enrollment and with no more than
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- 1 missed dose over this period
- At least two haemoglobin values within the target range of 100 to 130 g/L obtained at least 1 week apart and within 5 weeks of the baseline visit
- Subjects must have a haemoglobin of 100 to 130 g/L at eligibility/baseline
- Serum ferritin greater than or equal to 100 mg/L or transferrin saturation greater than or equal to 19.5%
- Serum vitamin B12 and folate levels must be above the lower limit of the normal range of the local laboratory
- Before any study specific procedure is performed, the subject must provide informed consent for participation in the study
Who cannot join
- Anticipating, scheduled for, or a prior recipient of a kidney transplant
- Uncontrolled hypertension (blood pressure greater than 160/100 mmHg during the eligibility/baseline period on 2 separate measurements)
- Congestive heart failure (New York Heart Association [NYHA] class III or IV)
- Clinical evidence of severe hyperparathyroidism (parathyroid hormone level greater than 1500 pg/mL or biopsy-proven bone marrow fibrosis)
- Major surgery within 12 weeks before enrollment (excluding vascular access surgery)
- Active chronic inflammatory process
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- Currently receiving antibiotic therapy for systemic infection
- ALT or AST greater than 2 times the upper limit of normal range
- Known positive HIV antibody or positive hepatitis B surface antigen
- Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
- Red blood cell transfusions within 8 weeks before eligibility visit or active bleeding
- Systemic hematologic disease (e.g., sickle cell anaemia, myelodysplastic syndromes, hematologic malignancy, myeloma, haemolytic anaemia)
- Psychiatric or any other disorder which may impact (in the judgment of the Investigator) the ability to give informed consent for participation in this study
- Pregnant or breast feeding women
- All subjects must practice adequate contraception in the judgment of the Investigator, during the course of their participation in the trial
- Previous entry in this study
- Treatment with an investigational agent other than Aranesp® or device within 30 days before the first dose of study drug or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study
About this study
Official title: An Open-Label Study of Aranesp® (Darbepoetin Alfa) Administration Once Every Four Weeks in Anaemic Chronic Kidney Disease (CKD) Subjects
The purpose of this study is to assess if Aranesp® administered once every 4 weeks to chronic kidney disease subjects is safe and efficacious in maintaining haemoglobin levels greater than or equal to 100 g/L.
- Conditions
- Kidney Disease
- Being tested
- Aranesp® (darbepoetin alfa)
- Keywords
- Chronic Kidney Disease (CKD), anemia, clinical trial, darbepoetin alfa, Aranesp®, Amgen
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aranesp® (darbepoetin alfa)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin level
Secondary outcomes (4)
Aranesp® doses
Adverse events
Laboratory parameters
Blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124098
- Sponsor's protocol ID
- 20030112
- Status last verified
- Jun 2008
- First submitted
- 30 Jun 2005
- Last updated
- 16 Jun 2008
- Results posted
- No
Publications
Disney A, Jersey PD, Kirkland G, Mantha M, Charlesworth JA, Gallagher M, Harris D, Gock H, Mangos GJ, Macmillan J, Liu W, Viswalingam A. Darbepoetin alfa administered monthly maintains haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis: a multicentre, open-label, Australian study. Nephrology (Carlton). 2007 Feb;12(1):95-101. doi: 10.1111/j.1440-1797.2006.00757.x.
PubMed 17295668
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Aranesp® (Darbepoetin Alfa) Administration Once Every Four Weeks in Anaemic Chronic Kidney Disease (CKD) Subjects
- ClinicalTrials.gov ID
- NCT00124098
- Acronym / sponsor ID
- 20030112
- Conditions
- Kidney Disease
- Keywords
- Chronic Kidney Disease (CKD), anemia, clinical trial, darbepoetin alfa, Aranesp®, Amgen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- First posted
- 27 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 if Aranesp® administered once every 4 weeks to chronic kidney disease subjects is safe and efficacious in maintaining haemoglobin levels greater than or equal to 100 g/L.
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
Key inclusion criteria (12 listed)
- Diagnosis of chronic kidney disease and not expected to initiate dialysis for the duration of the study
- Creatinine clearance greater than 15 and less than 40 mL/min as estimated by the Cockroft-Gault equation:
- Receiving stable every other week subcutaneous doses of Aranesp®.
- A stable dose is defined as less than or equal to 25% change in Aranesp® dose over the 6-week period immediately prior to enrollment and with no more than
- 1 missed dose over this period
Key exclusion criteria (17 listed)
- Anticipating, scheduled for, or a prior recipient of a kidney transplant
- Uncontrolled hypertension (blood pressure greater than 160/100 mmHg during the eligibility/baseline period on 2 separate measurements)
- Congestive heart failure (New York Heart Association [NYHA] class III or IV)
- Clinical evidence of severe hyperparathyroidism (parathyroid hormone level greater than 1500 pg/mL or biopsy-proven bone marrow fibrosis)
- Major surgery within 12 weeks before enrollment (excluding vascular access surgery)
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® (darbepoetin alfa) | Drug | – |
Primary outcome
Haemoglobin level
4 secondary outcomes
Aranesp® doses
Adverse events
Laboratory parameters
Blood pressure
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 Jun 2008.
- Results publication: PubMed 17295668Disney A, Jersey PD, Kirkland G, Mantha M, Charlesworth JA, Gallagher M, Harris D, Gock H, Mangos GJ, Macmillan J, Liu W, Viswalingam A. Darbepoetin alfa administered monthly maintains haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis: a multicentre, open-label, Australian study. Nephrology (Carlton). 2007 Feb;12(1):95-101. doi: 10.1111/j.1440-1797.2006.00757.x.
- 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® (darbepoetin alfa) 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?
The sponsor lists 12 inclusion and 17 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: finished, as of the sponsor's last update on 16 Jun 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?
Haemoglobin level. 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 NCT00124098, which also lists 1 linked publication.
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 Jun 2008.