Chronic Kidney DiseasePhase 3NCT00112008
Study for Subjects With Chronic Kidney Disease(CKD) Not Receiving Dialysis
A Phase 3 study testing De Novo Administration of Darbepoetin Alfa in people with Chronic Kidney Disease and Kidney Disease, run by Amgen.
Trial summary
The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who are not currently receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Kidney Disease
- What is being tested?
- De Novo Administration of Darbepoetin Alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Mar 2005
- 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: - Diagnosis of CKD and not expected to initiate dialysis for the duration of the study - Estimated glomerular filtration rate (eGFR): greater than or equal to 15 mL/min and less than or equal to 60 mL/min measured by the following modified MDRD (Modification of Diet in Renal Disease) equation: eGFR = 186 x [serum creatinine]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.212 if subject is black] - Clinically stable, in the judgment of the investigator - Mean Hb greater than or equal to 11.0 g/dL to less than or equal to 13.0 g/dL (mean of 2 values drawn at least 3 days apart during the screening period) - Transferrin saturation (Tsat) greater than or equal to 15.0% - Serum vitamin B12 and folate levels above the lower limit of the normal range - Receiving stable Q2W subcutaneous (SC) doses of Aranesp® (darbepoetin alfa). A stable dose is defined as less than or equal to a 25% change in dose over the 6-week period immediately prior to enrollment and with no missed doses in this period Exclusion Criteria: - Prior recipient or scheduled to receive a kidney transplant - Diastolic blood pressure (BP) greater than 110 mm Hg or systolic BP greater than 180 mm Hg during screening - Acute myocardial ischemia - Hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment - Parathyroid hormone level greater than 1500 pg/mL - Major surgery within 12 weeks before enrollment (excluding vascular access surgery) - Currently receiving antibiotic therapy for systemic infection - 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 (RBC) transfusions within 8 weeks before enrollment - Androgen therapy within 8 weeks before enrollment - Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia) - Any disorder that 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) throughout this trial - Treatment with an investigational agent or device within 30 days before enrollment 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: A Multi-Center, Single-Arm Study Evaluating De Novo Once Every Two Week Darbepoetin Alfa Dosing in Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who are not currently receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.
- Conditions
- Chronic Kidney Disease, Kidney Disease
- Being tested
- De Novo Administration of Darbepoetin Alfa
- Keywords
- Anemia
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De Novo Administration of Darbepoetin AlfaDrug
Administration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL
| Study group | Role | What they receive |
|---|---|---|
| darbepoetin alfa | Experimental | Not described Receives: Drug: De Novo Administration of Darbepoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects achieving a Hb ≥ 11.0 g/dL
Measured: Entire Study
Secondary outcomes (3)
Hb values over the duration of the study
Measured: Entire Study
Darbepoetin alfa doses over the duration of the study
Measured: Entire Study
Frequency, severity, and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure
Measured: Entire Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2005 (estimated)
- Study startMay 2004
- Primary completionMar 2005
- Study completionMar 2005
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 Chronic 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112008
- Sponsor's protocol ID
- 20030237
- Status last verified
- Jul 2009
- First submitted
- 27 May 2005
- Last updated
- 10 Jul 2009
- Results posted
- No
Publications
Silver MR, Geronemus R, Krause M, Chen CY, Kewalramani R, Stehman-Breen C. Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naive to erythropoiesis-stimulating agents. Curr Med Res Opin. 2009 Jan;25(1):123-31. doi: 10.1185/03007990802594818.
PubMed 19210145
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Single-Arm Study Evaluating De Novo Once Every Two Week Darbepoetin Alfa Dosing in Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
- ClinicalTrials.gov ID
- NCT00112008
- Acronym / sponsor ID
- 20030237
- Conditions
- Chronic Kidney Disease, Kidney Disease
- Keywords
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 30 May 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 proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who are not currently receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| darbepoetin alfa | Experimental | Drug: De Novo Administration of Darbepoetin Alfa |
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 |
|---|---|---|
| De Novo Administration of Darbepoetin AlfaAdministration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL | Drug | darbepoetin alfa |
Primary outcome
The proportion of subjects achieving a Hb ≥ 11.0 g/dL
Time frame: Entire Study
3 secondary outcomes
Hb values over the duration of the study
Time frame: Entire Study
Darbepoetin alfa doses over the duration of the study
Time frame: Entire Study
Frequency, severity, and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure
Time frame: Entire Study
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 10 Jul 2009.
- Results publication: PubMed 19210145Silver MR, Geronemus R, Krause M, Chen CY, Kewalramani R, Stehman-Breen C. Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naive to erythropoiesis-stimulating agents. Curr Med Res Opin. 2009 Jan;25(1):123-31. doi: 10.1185/03007990802594818.
- 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 De Novo Administration of Darbepoetin Alfa in people with Chronic Kidney Disease and 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 10 Jul 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 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?
The proportion of subjects achieving a Hb ≥ 11.0 g/dL (time frame: Entire Study). 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 NCT00112008, 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 10 Jul 2009.