AnemiaPhase 4NCT00117065
Study of Transplant Related Anemia Treated With Aranesp® (STRATA)
A Phase 4 study testing Aranesp® in people with Anemia, run by Amgen.
Trial summary
The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- 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 who are greater than 6 months post-renal transplant (living or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential - Available for follow-up assessments and dosing visits - Hb concentration less than 11.0 g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period Exclusion Criteria: - Expected to initiate dialysis or transplantation or be scheduled for a kidney transplant within 6 months of study start, or have less than 1 year life expectancy - Systemic hematologic disease, myeloma, hemolytic anemia, or malignancy (excluding basal cell carcinoma) - Active systemic or chronic infection - Uncontrolled hypertension defined as diastolic blood pressure greater than 110 mm Hg on 2 separate occasions during the 2 weeks prior to screening - Known hypersensitivity to Aranesp® or any of the product's excipients - Disorders that compromise the ability of the subject to give written informed consent and/or to comply with study procedures - Use of any erythropoietic protein or androgen therapy within the 12 weeks prior to screening - Females who are pregnant or breast-feeding - Currently enrolled in or received treatment in an investigational drug/device trial within the past 30 days - Have previously been enrolled in this study - Recent history (within 12 weeks prior to screening) of severe cardiovascular events, grand mal seizure, dialysis or major surgery - Have received a red blood cell transfusion(s) within 8 weeks prior to screening, or currently have active bleeding
About this study
The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients.
- Conditions
- Anemia
- Being tested
- Aranesp®
- Keywords
- Kidney transplant, Renal transplant, Aranesp®, Darbepoetin alfa, Amgen, Q2W dosing, Q4W dosing
- Medical subject headings
- 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.
Hemoglobin values
Secondary outcomes (1)
SF-36 summary and individual domain scores at week 24
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117065
- Sponsor's protocol ID
- 20030139
- Status last verified
- Apr 2013
- First submitted
- 30 Jun 2005
- Last updated
- 26 Apr 2013
- Results posted
- No
Publications
Bloom RD, Bolin P, Gandra SR, Scarlata D, Petersen J. Impact on health-related quality of life in kidney transplant recipients with late posttransplant anemia administered darbepoetin alfa: results from the STRATA study. Transplant Proc. 2011 Jun;43(5):1593-600. doi: 10.1016/j.transproceed.2011.02.009.
PubMed 21693239
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Transplant Related Anemia Treated With Aranesp® (STRATA)
- ClinicalTrials.gov ID
- NCT00117065
- Acronym / sponsor ID
- 20030139
- Conditions
- Anemia
- Keywords
- Kidney transplant, Renal transplant, Aranesp®, Darbepoetin alfa, Amgen, Q2W dosing, Q4W dosing
- 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 was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients.
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
Hemoglobin values
1 secondary outcome
SF-36 summary and individual domain scores at week 24
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 26 Apr 2013.
- Results publication: PubMed 21693239Bloom RD, Bolin P, Gandra SR, Scarlata D, Petersen J. Impact on health-related quality of life in kidney transplant recipients with late posttransplant anemia administered darbepoetin alfa: results from the STRATA study. Transplant Proc. 2011 Jun;43(5):1593-600. doi: 10.1016/j.transproceed.2011.02.009.
- 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 4 study testing Aranesp® in people with Anemia, 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 26 Apr 2013. 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?
Hemoglobin values. 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 NCT00117065, 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 26 Apr 2013.