Pre-DialysisPhase 2NCT00527215
Phase 2 Study of Darbepoetin Alfa Extended Dosing
A Phase 2 study testing darbepoetin alfa in people with Pre-Dialysis, run by Amgen.
Trial summary
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-Dialysis
- What is being tested?
- darbepoetin alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Oct 2003
- Phase
- Phase 2
- 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
- Greater than or equal to 18 years of age
- CRI with a creatinine clearance of greater than 15 but less than 40 mL/min
- Stable once every other week darbepoetin alfa SC for at least 6 weeks
- Hb values during screening / baseline of 10.0 - 12.0 g/dL
- Serum B12 and folate levels above the lower limit of normal and iron replete
Who cannot join
- Receiving renal replacement therapy
- Uncontrolled hypertension
- Hyperparathyroidism
- Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive
- Current malignancy
- Pregnant or breast-feeding
About this study
Official title: A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal Insufficiency (CRI) Subjects With Anemia
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.
- Conditions
- Pre-Dialysis
- Being tested
- darbepoetin alfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darbepoetin alfaDrug
starting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 10.0 - 12.0 g.dL
| Study group | Role | What they receive |
|---|---|---|
| darbepoetin alfa | Experimental | Not described Receives: Drug: darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks
Measured: Study weeks 21 - 29
Secondary outcomes (1)
To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks.
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 posted10 Sep 2007 (estimated)
- Study startMar 2002
- Primary completionOct 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-DialysisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527215
- Sponsor's protocol ID
- 20010212
- Status last verified
- May 2009
- First submitted
- 6 Sep 2007
- Last updated
- 22 May 2009
- Results posted
- No
Publications
Ling B, Walczyk M, Agarwal A, Carroll W, Liu W, Brenner R. Darbepoetin alfa administered once monthly maintains hemoglobin concentrations in patients with chronic kidney disease. Clin Nephrol. 2005 May;63(5):327-34. doi: 10.5414/cnp63327.
PubMed 15909591Agarwal A, Silver MR, Walczyk M, Liu W, Audhya P. Once-monthly darbepoetin alfa for maintaining hemoglobin levels in older patients with chronic kidney disease. J Am Med Dir Assoc. 2007 Feb;8(2):83-90. doi: 10.1016/j.jamda.2006.07.007. Epub 2006 Sep 29.
PubMed 17289537
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal Insufficiency (CRI) Subjects With Anemia
- ClinicalTrials.gov ID
- NCT00527215
- Acronym / sponsor ID
- 20010212
- Conditions
- Pre-Dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 10 Sep 2007 (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.
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.
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: darbepoetin alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Greater than or equal to 18 years of age
- CRI with a creatinine clearance of greater than 15 but less than 40 mL/min
- Stable once every other week darbepoetin alfa SC for at least 6 weeks
- Hb values during screening / baseline of 10.0 - 12.0 g/dL
- Serum B12 and folate levels above the lower limit of normal and iron replete
Key exclusion criteria (6 listed)
- Receiving renal replacement therapy
- Uncontrolled hypertension
- Hyperparathyroidism
- Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive
- Current malignancy
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 |
|---|---|---|
| darbepoetin alfastarting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 10.0 - 12.0 g.dL | Drug | darbepoetin alfa |
Primary outcome
To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks
Time frame: Study weeks 21 - 29
1 secondary outcome
To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks.
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 22 May 2009.
- Results publication: PubMed 15909591Ling B, Walczyk M, Agarwal A, Carroll W, Liu W, Brenner R. Darbepoetin alfa administered once monthly maintains hemoglobin concentrations in patients with chronic kidney disease. Clin Nephrol. 2005 May;63(5):327-34. doi: 10.5414/cnp63327.
- Results publication: PubMed 17289537Agarwal A, Silver MR, Walczyk M, Liu W, Audhya P. Once-monthly darbepoetin alfa for maintaining hemoglobin levels in older patients with chronic kidney disease. J Am Med Dir Assoc. 2007 Feb;8(2):83-90. doi: 10.1016/j.jamda.2006.07.007. Epub 2006 Sep 29.
- FDA-approved Drug LabelingLink provided by the sponsor.
- 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 2 study testing darbepoetin alfa in people with Pre-Dialysis, 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 5 inclusion and 6 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 22 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks (time frame: Study weeks 21 - 29). 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 NCT00527215, which also lists 2 linked publications.
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 22 May 2009.