AnemiaPhase 3NCT00364845
STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
A Phase 3 study testing Darbepoetin alfa in people with Anemia and Chronic Kidney Disease, run by Amgen.
Trial summary
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Anemia, Chronic Kidney Disease
- What is being tested?
- Darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Feb 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Stage 3-5 CKD not on dialysis
- Patients ≥ 70 years of age
- Haemoglobin < 110g/L at screening
- Transferrin saturation ≥ 15% at screening
Who cannot join
- Clinical history of type 2 diabetes mellitus
- Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant
- Uncontrolled hypertension on two separate measurements during screening
- Use of any erythropoietic protein within 12 weeks of screening
About this study
Official title: A Randomised Single-Blind Study to Improve Health-related Quality of Life as Measured by the Short-Form 36 (SF-36) Vitality Score by Correcting Anemia With Aranesp (Darbepoetin Alfa) in the Elderly.
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks
Read the detailed description
This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.
- Conditions
- Anemia, Chronic Kidney Disease
- Being tested
- Darbepoetin alfa, Placebo
- Keywords
- Quality of Life, Chronic Kidney Disease, Anemia
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Also called Aranesp®
Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion.
PlaceboDrug
Prefilled syringe placebo, to match active arm
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa | Active comparator | Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months. Receives: Drug: Darbepoetin alfa |
| Placebo | Placebo comparator | Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Measured: Week 24
Secondary outcomes (3)
Number of Participants With Hemoglobin (Hb) ≥ 110 g/L
Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.
Measured: Evaluation Period (Weeks 22-36)
Mean Hemoglobin During the Evaluation Period
Measured: Evaluation Period (Weeks 22-36)
Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24
The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2008
- Study completionFeb 2009
Why it stopped: The reason for the discontinuation of the study is difficulty with recruitment and timely enrolment and is not related to safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
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
- NCT00364845
- Sponsor's protocol ID
- 20050122
- Status last verified
- Apr 2014
- First submitted
- 14 Aug 2006
- Last updated
- 21 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Single-Blind Study to Improve Health-related Quality of Life as Measured by the Short-Form 36 (SF-36) Vitality Score by Correcting Anemia With Aranesp (Darbepoetin Alfa) in the Elderly.
- ClinicalTrials.gov ID
- NCT00364845
- Acronym / sponsor ID
- 20050122
- Conditions
- Anemia, Chronic Kidney Disease
- Keywords
- Quality of Life, Chronic Kidney Disease, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The reason for the discontinuation of the study is difficulty with recruitment and timely enrolment and is not related to safety concerns
- Enrolment
- 51 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Aug 2006 (estimated)
- Results
- Posted 21 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks
Detailed description
This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa | Active comparator | Drug: Darbepoetin alfaSingle-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months. |
| Placebo | Placebo comparator | Drug: PlaceboSingle-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Stage 3-5 CKD not on dialysis
- Patients ≥ 70 years of age
- Haemoglobin < 110g/L at screening
- Transferrin saturation ≥ 15% at screening
Key exclusion criteria (4 listed)
- Clinical history of type 2 diabetes mellitus
- Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant
- Uncontrolled hypertension on two separate measurements during screening
- Use of any erythropoietic protein within 12 weeks of screening
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 alfaAlso: Aranesp®Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion. | Drug | Darbepoetin alfa |
| PlaceboPrefilled syringe placebo, to match active arm | Drug | Placebo |
Primary outcome
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24
Time frame: Week 24
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
3 secondary outcomes
Number of Participants With Hemoglobin (Hb) ≥ 110 g/L
Time frame: Evaluation Period (Weeks 22-36)
Mean Hemoglobin During the Evaluation Period
Time frame: Evaluation Period (Weeks 22-36)
Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
- 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 3 study testing Darbepoetin alfa in people with Anemia and Chronic 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 21 May 2014. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24 (time frame: Week 24). 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 NCT00364845, 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 21 May 2014.