Chronic Kidney DiseasePhase 3DIAMONDNCT01478971
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
A Phase 3 study testing Epoetin and Peginesatide in people with Chronic Kidney Disease and Anemia, run by Takeda at 5 sites in United States.
Trial summary
The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Anemia
- What is being tested?
- Epoetin and Peginesatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2011to Feb 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have provided written informed consent in accordance with institutional, local, and national guidelines
- Are ≥18 years of age at the start of screening
- Have been on in-center hemodialysis for ≥12 weeks at the start of screening
- Are currently maintained on Epoetin at the start of screening
- If sexually active and a female of childbearing potential, are willing to use highly effective method of birth control ≥4 weeks before study enrollment and through the study
- If a female of childbearing potential, have a negative pregnancy test during screening
Who cannot join
- Are scheduled for a renal transplantation during study (Note: patients awaiting transplantation with no date scheduled may enroll.)
- Have an active malignancy or malignancy treated within one year prior to the start of screening for curative or palliative intent (Note: patients with non-melanoma skin cancers may enroll.)
- Have known intolerance to any ESA or PEGylated molecule
- Have been exposed to any investigational agent during the four weeks prior to the start of screening or are anticipated to receive such agents during the study
- Have any significant medical or psychiatric condition judged by the investigator to prevent informed consent or study compliance
- Are pregnant or nursing
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Facility
North Brunswick, New Jersey, 08902
Research Facility
Sacramento, California, 95825
Research Facility
San Antonio, Texas, 78215
Research Facility
San Diego, California, 91910
Research Facility
San Jose, California, 95128
About this study
Official title: A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.
Read the detailed description
Monthly Erythropoiesis-Stimulating Agents (ESA) dosing, compared with the longstanding practice of dosing three times per week, represents a significant change in anemia treatment for dialysis patients. Because of the differences in the processes needed to support monthly dosing versus thrice weekly dosing, there is a need to prospectively identify and evaluate factors in the dialysis environment during center-level transition of patients from one ESA to another.
AFX01-18 is a Phase 3b open-label, single-arm conversion study that was conducted at 5 hemodialysis sites in the United States, and enrolled Chronic Kidney Disease (CKD) patients receiving outpatient, in-center hemodialysis. The study treatment period was approximately 12 months in duration. Participants received peginesatide injection for approximately six months.
- Conditions
- Chronic Kidney Disease, Anemia
- Being tested
- Epoetin, Peginesatide
- Keywords
- Anemia, Chronic Renal Failure, CRF, Chronic Kidney Disease, CKD, Erythropoietin, Hematide, Peginesatide, Hemoglobin, Hgb, Red Blood Cell, Red Blood Cell Production, Dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpoetinDrug
Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous [IV] or subcutaneous [SC]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of <11 g/dL.
PeginesatideDrug
Also called Omontys
Administered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at <11 g/dL.
| Study group | Role | What they receive |
|---|---|---|
| peginesatide injection | Experimental | In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]). Receives: Drug: Epoetin; Drug: Peginesatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Undergoing Conversion to Peginesatide Injection
Measured: 6 months
Secondary outcomes (5)
Peginesatide Dosing
The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.
Measured: Month 6 - 12
Peginesatide Dose Deviations
Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.
Measured: Months 6 - 12
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL
Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.
Measured: Months 1, 2, 3, 4, 5 and 6 of each treatment period
Percentage of Participants Who Received at Least One Intravenous Iron Dose
Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.
Measured: 12 months
Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affymax
- Responsible party
- Sponsor
- Investigators
- Medical Director, Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478971
- Sponsor's protocol ID
- AFX01-18
- Other IDs
- U1111-1150-2575
- Acronym
- DIAMOND
- Status last verified
- Sep 2016
- First submitted
- 22 Nov 2011
- Last updated
- 20 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
- ClinicalTrials.gov ID
- NCT01478971
- Acronym / sponsor ID
- DIAMOND / AFX01-18
- Conditions
- Chronic Kidney Disease, Anemia
- Keywords
- Anemia, Chronic Renal Failure, CRF, Chronic Kidney Disease, CKD, Erythropoietin, Hematide, Peginesatide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Affymax
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Posted 26 May 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 understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.
Detailed description
Monthly Erythropoiesis-Stimulating Agents (ESA) dosing, compared with the longstanding practice of dosing three times per week, represents a significant change in anemia treatment for dialysis patients. Because of the differences in the processes needed to support monthly dosing versus thrice weekly dosing, there is a need to prospectively identify and evaluate factors in the dialysis environment during center-level transition of patients from one ESA to another.
AFX01-18 is a Phase 3b open-label, single-arm conversion study that was conducted at 5 hemodialysis sites in the United States, and enrolled Chronic Kidney Disease (CKD) patients receiving outpatient, in-center hemodialysis. The study treatment period was approximately 12 months in duration. Participants received peginesatide injection for approximately six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peginesatide injection | Experimental | Drug: Epoetin, Drug: PeginesatideIn the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have provided written informed consent in accordance with institutional, local, and national guidelines
- Are ≥18 years of age at the start of screening
- Have been on in-center hemodialysis for ≥12 weeks at the start of screening
- Are currently maintained on Epoetin at the start of screening
- If sexually active and a female of childbearing potential, are willing to use highly effective method of birth control ≥4 weeks before study enrollment and through the study
Key exclusion criteria (6 listed)
- Are scheduled for a renal transplantation during study (Note: patients awaiting transplantation with no date scheduled may enroll.)
- Have an active malignancy or malignancy treated within one year prior to the start of screening for curative or palliative intent (Note: patients with non-melanoma skin cancers may enroll.)
- Have known intolerance to any ESA or PEGylated molecule
- Have been exposed to any investigational agent during the four weeks prior to the start of screening or are anticipated to receive such agents during the study
- Have any significant medical or psychiatric condition judged by the investigator to prevent informed consent or study compliance
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 |
|---|---|---|
| EpoetinCommercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous [IV] or subcutaneous [SC]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of <11 g/dL. | Drug | peginesatide injection |
| PeginesatideAlso: OmontysAdministered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at <11 g/dL. | Drug | peginesatide injection |
Primary outcome
Percentage of Participants Undergoing Conversion to Peginesatide Injection
Time frame: 6 months
5 secondary outcomes
Peginesatide Dosing
Time frame: Month 6 - 12
Peginesatide Dose Deviations
Time frame: Months 6 - 12
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL
Time frame: Months 1, 2, 3, 4, 5 and 6 of each treatment period
Percentage of Participants Who Received at Least One Intravenous Iron Dose
Time frame: 12 months
Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director, Clinical Science study director
Takeda
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin and Peginesatide in people with Chronic Kidney Disease and Anemia, run by Takeda at 5 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 6 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 26 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?
Percentage of Participants Undergoing Conversion to Peginesatide Injection (time frame: 6 months). 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 20 Sep 2016.