AnemiaPhase 4NCT01737879
Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis
A Phase 4 study testing Peginesatide and Epoetin alfa in people with Anemia, run by Amgen at 23 sites in United States.
Trial summary
The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Peginesatide and Epoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 23 sitesUnited States
- Study dates
- Oct 2012to Jul 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving hemodialysis 3 times a week
- Receiving epoetin alfa IV 3 times a week
- Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening
Who cannot join
- Systemic hematologic disease
- Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during screening
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Research Site
Amherst, New York, 14221
Research Site
Azusa, California, 91702
Research Site
Bakersfield, California, 93309
Research Site
Bayonne, New Jersey, 07002
Research Site
Chesapeake, Virginia, 23320
Research Site
Dyersburg, Tennessee, 38024
Research Site
Granada Hills, California, 91344
Research Site
Houston, Texas, 77004
Research Site
Jackson, Tennessee, 38305
Research Site
Kansas City, Missouri, 64111
Research Site
Los Angeles, California, 90057
Research Site
Lynwood, California, 90262
Research Site
Meridian, Idaho, 83642
Research Site
Oklahoma City, Oklahoma, 73116
Research Site
Orange, Connecticut, 06477
Research Site
Orangeburg, South Carolina, 29118
Research Site
Paramount, California, 90723
Research Site
Phoenix, Arizona, 85004
Research Site
Riverside, California, 92501
Research Site
Tempe, Arizona, 85284
Research Site
Whittier, California, 90603
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Yonkers, New York, 10704
About this study
Official title: Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis
The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.
Read the detailed description
This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.
- Conditions
- Anemia
- Being tested
- Peginesatide, Epoetin alfa
- Keywords
- Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeginesatideDrug
Also called Omontys
All participants will receive peginesatide for the first 24 weeks.
Epoetin alfaDrug
Also called Epogen
All participants converted to epoetin alfa at week 25 for a total of 32 weeks
| Study group | Role | What they receive |
|---|---|---|
| Peginesatide / Epoetin Alfa | Experimental | Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks. Receives: Drug: Peginesatide; Drug: Epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hemoglobin Concentration During the Evaluation Period
The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants.
No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.
Measured: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Secondary outcomes (3)
Mean Dose of Epoetin Alfa During the Evaluation Period
No participant reached the evaluation period, therefore, this endpoint could not be evaluated.
Measured: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Hemoglobin Concentration by Visit
Measured: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21
Peginesatide Dose by Visit
Measured: Baseline and Weeks 5, 9, 13, and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionJul 2013
Why it stopped: Terminated: Test article, Omontys, was recalled from the market; Enrollment has halted prematurely and will not resume; participants are no longer being treated
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT01737879
- Sponsor's protocol ID
- 20110209
- Status last verified
- Mar 2014
- First submitted
- 3 Oct 2012
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT01737879
- Acronym / sponsor ID
- 20110209
- Conditions
- Anemia
- Keywords
- Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated: Test article, Omontys, was recalled from the market; Enrollment has halted prematurely and will not resume; participants are no longer being treated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Posted 21 Apr 2014
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 evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.
Detailed description
This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginesatide / Epoetin Alfa | Experimental | Drug: Peginesatide, Drug: Epoetin alfaParticipants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving hemodialysis 3 times a week
- Receiving epoetin alfa IV 3 times a week
- Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening
Key exclusion criteria (2 listed)
- Systemic hematologic disease
- Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during 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 |
|---|---|---|
| PeginesatideAlso: OmontysAll participants will receive peginesatide for the first 24 weeks. | Drug | Peginesatide / Epoetin Alfa |
| Epoetin alfaAlso: EpogenAll participants converted to epoetin alfa at week 25 for a total of 32 weeks | Drug | Peginesatide / Epoetin Alfa |
Primary outcome
Mean Hemoglobin Concentration During the Evaluation Period
Time frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants. No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.
3 secondary outcomes
Mean Dose of Epoetin Alfa During the Evaluation Period
Time frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Hemoglobin Concentration by Visit
Time frame: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21
Peginesatide Dose by Visit
Time frame: Baseline and Weeks 5, 9, 13, and 17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginesatide and Epoetin alfa in people with Anemia, run by Amgen at 23 sites in United States.
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 3 inclusion and 2 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 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 21 Apr 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?
Mean Hemoglobin Concentration During the Evaluation Period (time frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2014.