Chronic Kidney Disease (CKD)Phase 3NCT02504294
A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
A Phase 3 study testing Epoetin Hospira Arm and IV Iron in people with Chronic Kidney Disease (CKD), run by Pfizer at 45 sites in 2 countries.
Trial summary
A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- Epoetin Hospira Arm and IV Iron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 45 sitesin 2 countries
- Study dates
- 13 Jul 2015to 16 Jul 2016
- 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
- Subjects eligible to be entered into the study will meet all of the following criteria:
- Adult female or male subjects; age ≥ 18 years.
- End stage renal disease subjects treated in-center with the modality of hemodialysis for ≥ 120 days.
- Diagnosed with anemia.
- Administered routine Epogen therapy for at least 16 weeks by an IV route for treatment of anemia using an Epogen version of an FMCNA dosing algorithm for ESA, and did not miss more than 3 prescribed doses of Epogen within 12 weeks prior to randomization.
- Currently using the IV Epogen version of the ESA dosing algorithm cMAB 5 (inclusive of versions 5.0, 5.1, …) for anemia management.
- Receiving hemodialysis at a clinic using the FMCNA dosing algorithm for IV iron that is the FMCNA standard of care treatment for iron replacement.
Who cannot join
- Subjects that meet any of the following criteria will be ineligible to be entered into the interventional cohort:
- Subjects unable to provide a signed and dated informed consent for this clinical research study.
- As determined by the Investigator, female subjects of child bearing potential who do not agree to use a highly effective method of contraception.
- Any condition as determined by the investigator that would place a subject at an increased risk, or preclude subject's full compliance with the study procedures and visits.
- Female subjects who are known to be or found to be, pregnant or lactating.
- Subjects that are not a candidate for ESA therapies per the label warnings listed in the package insert for Epogen and/or contraindications to Epoetin Hospira listed in the Investigators' Brochure; or have had a known positive test for anti-rhEPO antibodies.
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- Treatment with any investigational drug within 30 days prior to randomization and throughout this clinical trial.
- Diagnosed with any concurrent condition that could lead to greater-than-normal loss of blood, including but not limited to:
- Menorrhagia, peptic ulcer disease, gastrointestinal bleeding, blood dyscrasia, hemoglobinopathy
- Use of anticoagulation therapy, including warfarin with a target international normalized ratio (INR) of 2 or greater Anti-platelet therapy (e.g. aspirin or clopidogrel) is permitted, as is heparin given during hemodialysis. Low-dose warfarin is permitted and defined as the presence of at least two INR values less than or equal to 1.5 during the 120 days prior to enrollment and no values exceeding 1.5 at any time after 120 days prior to enrollment.
- Subjects started on warfarin with a known INR goal of 2.0 or greater are to receive no further treatment with the study drugs, but follow up visits can continue.
- Subjects on warfarin who meet criteria to enter the study are terminated if an INR > 2.0 is discovered or if no INR is available for 60 days.
- History of transfusion of any blood product in the past 3 months, or 2 or more transfusions in the past 1 year; or donated or lost > 475 mL blood volume (including plasmapheresis) in the past 3 months.
- Subjects currently receiving a long acting ESA, or who have received a long acting ESA in the 16 weeks prior to study randomization
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States42 sites
Fresenius Medical Care - Austin North 4478
Austin, Texas, 78758
Research Management Inc
Austin, Texas, 78758
Fresenius Medical Care, Biloxi Dialysis Unit
Biloxi, Mississippi, 39530
Frenova Renal Research
Boise, Idaho, 83702
Fresenius Medical Care North America - Liberty Dialysis
Boise, Idaho, 83702
Frenova Renal Research
Caldwell, Idaho, 83605
Fresenius Medical Care North America - Liberty Dialysis
Caldwell, Idaho, 83605
FMC Charlotte
Charlotte, North Carolina, 28204
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28204
California Institute of Renal Research
Chula Vista, California, 91910
Fresenius Crossville Dialysis Unit
Crossville, Tennessee, 38555
Briggs Avenue Dialysis Center
Durham, North Carolina, 27703
Durham Nephrology Associates
Durham, North Carolina, 27704
Fresenius Medical Care-Franklin
Franklin, Tennessee, 37067
North Gulfport
Gulfport, Mississippi, 39501
South Mississippi Kidney Center
Gulfport, Mississippi, 39503
Mission Bend Dialysis (FMC#3971)
Houston, Texas, 77083
Southwest Houston Research, Ltd.
Houston, Texas, 77099
Fresenius Medical Care-Kalamazoo East
Kalamazoo, Michigan, 49001
Paragon Health PC DBA Nephrology Center
Kalamazoo, Michigan, 49007
Fresenius Medical Care-Oshtemo
Kalamazoo, Michigan, 49009
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923
Fresenius Dialysis West
Knoxville, Tennessee, 37934
Fresenius Medical Care- Lansdale Dialysis
Lansdale, Pennsylvania, 19446
FMC Matthews
Matthews, North Carolina, 28105
Gamma Medical Research Inc
McAllen, Texas, 78503
Frenova Renal Research
Meridian, Idaho, 83642
Fresenius Medical Care North America - Liberty Dialysis
Meridian, Idaho, 83642
Frenova Renal Research
Nampa, Idaho, 83686
Fresenius Medical Care North America - Liberty Dialysis
Nampa, Idaho, 83686
Nephrology Associates, PC
Nashville, Tennessee, 37205
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, 19118
California Institute of Renal Research at Fresenius Medical Care
Poway, California, 92064
Fresenius Medical Care Rancho
Rancho Bernardo, California, 92127
Rosenberg Dialysis (FMC#1197)
Rosenberg, Texas, 77471
California Institute of Renal Research at Fresenius Medical Care Kearny Mesa
San Diego, California, 92111
Fresenius Medical Care Paradise Valley
San Diego, California, 92139
Fresenius Medical Care
Tampa, Florida, 33609
Fresenius Medical Care
Tampa, Florida, 33610
Genesis Clinical Research, LLC
Tampa, Florida, 33614
Fresenius Medical Care
Warwick, Rhode Island, 02886
Fresenius Medical Care Weslaco
Weslaco, Texas, 78596
Puerto Rico3 sites
Fresenius Medical Care Carolina
Carolina, 00983
Fresenius Medical Care
Humacao, 00791
Fresenius Medical Care San Juan
San Juan, 00917
About this study
Official title: The Pieda Study: A Phase 3b Investigation Of Erythropoietin Drugs Using A Specified Dosing Algorithm: A Randomized Open Label Dosing Study In Adult Chronic Kidney Disease Subjects On Hemodialysis
A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.
Read the detailed description
Primary Objective: To evaluate switching from Epogen to Epoetin Hospira for maintenance of hemoglobin levels in anemic chronic kidney disease (CKD) subjects on hemodialysis using a specified algorithm for the dosing of erythropoietin stimulating agents (ESA).
Secondary Objective: To evaluate switching from Epogen to Epoetin Hospira on the dosing of ESA in anemic CKD subjects on hemodialysis using a specified algorithm for the dosing of ESA.
Exploratory Objectives: To generate hypotheses regarding maintenance of hemoglobin levels, dosing of ESA, intravenous (IV) iron dosing requirements, transferrin saturation (TSAT) levels and ferritin levels associated with the switch from Epogen to Epoetin Hospira in anemic CKD subjects on hemodialysis using specified algorithms for the dosing of ESA and for the dosing of IV iron, that are standard of care.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- Epoetin Hospira Arm, Standard of Care Arm, IV Iron
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin Hospira ArmBiological
Epoetin Hospira Arm: Epoetin Hospira will be administered intravenously (IV) per the analogous version of the Fresenius Medical Care North America (FMCNA) cMAB 1 (inclusive of version 1.0, 1.1,...)erythropoietin stimulating agents (ESA) dosing algorithm for Epoetin Hospira for 24 weeks. Subjects will have Epoetin Hospira initiated using the same ESA dose level and frequency of administration for Epogen prior to randomization into the trial. Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Standard of Care ArmOther
Standard of care arm: No interventions will be performed in this arm for the clinical study; and subjects will receive ongoing standard of care, which includes Epogen administered IV per the FMCNA cMAB 5 (inclusive of versions 5.0, 5.1,....) ESA dosing algorithm and IV iron per the FMCNA protocol that is standard of care, at FMCNA clinics during the contemporaneous 24 week period.
IV IronDrug
Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
| Study group | Role | What they receive |
|---|---|---|
| Epoetin Hospira | Other | Epoetin Hospira Arm Receives: Biological: Epoetin Hospira Arm; Drug: IV Iron |
| Standard of Care | Other | Standard of care arm Receives: Other: Standard of Care Arm; Drug: IV Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)
Measured: Week 17 up to Week 24
Secondary outcomes (1)
Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment
Measured: Baseline (8 Weeks prior to randomization), Week 17 up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study start13 Jul 2015
- Primary completion2 Jul 2016
- Study completion16 Jul 2016
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504294
- Sponsor's protocol ID
- ZIN-EPO-1503
- Other IDs
- C3461008
- Status last verified
- May 2018
- First submitted
- 20 Jul 2015
- Last updated
- 13 Jun 2018
- 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 36791280Thadhani R, Guilatco R, Hymes J, Maddux FW, Ahuja A. Switching from Epoetin Alfa (Epogen(R)) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis. Am J Nephrol. 2018;48(3):214-224. doi: 10.1159/000492621. Epub 2018 Sep 7.
PubMed 30196301
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pieda Study: A Phase 3b Investigation Of Erythropoietin Drugs Using A Specified Dosing Algorithm: A Randomized Open Label Dosing Study In Adult Chronic Kidney Disease Subjects On Hemodialysis
- ClinicalTrials.gov ID
- NCT02504294
- Acronym / sponsor ID
- ZIN-EPO-1503
- Conditions
- Chronic Kidney Disease (CKD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- 13 Jul 2015 (actual)
- Primary completion
- 2 Jul 2016 (actual)
- Study completion
- 16 Jul 2016 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Posted 13 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.
Detailed description
Primary Objective: To evaluate switching from Epogen to Epoetin Hospira for maintenance of hemoglobin levels in anemic chronic kidney disease (CKD) subjects on hemodialysis using a specified algorithm for the dosing of erythropoietin stimulating agents (ESA).
Secondary Objective: To evaluate switching from Epogen to Epoetin Hospira on the dosing of ESA in anemic CKD subjects on hemodialysis using a specified algorithm for the dosing of ESA.
Exploratory Objectives: To generate hypotheses regarding maintenance of hemoglobin levels, dosing of ESA, intravenous (IV) iron dosing requirements, transferrin saturation (TSAT) levels and ferritin levels associated with the switch from Epogen to Epoetin Hospira in anemic CKD subjects on hemodialysis using specified algorithms for the dosing of ESA and for the dosing of IV iron, that are standard of care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epoetin Hospira | Other | Biological: Epoetin Hospira Arm, Drug: IV IronEpoetin Hospira Arm |
| Standard of Care | Other | Other: Standard of Care Arm, Drug: IV IronStandard of care arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult female or male subjects; age ≥ 18 years.
- End stage renal disease subjects treated in-center with the modality of hemodialysis for ≥ 120 days.
- Diagnosed with anemia.
- Administered routine Epogen therapy for at least 16 weeks by an IV route for treatment of anemia using an Epogen version of an FMCNA dosing algorithm for ESA, and did not miss more than 3 prescribed doses of Epogen within 12 weeks prior to randomization.
- Currently using the IV Epogen version of the ESA dosing algorithm cMAB 5 (inclusive of versions 5.0, 5.1, …) for anemia management.
Key exclusion criteria (14 listed)
- Subjects that meet any of the following criteria will be ineligible to be entered into the interventional cohort:
- Subjects unable to provide a signed and dated informed consent for this clinical research study.
- As determined by the Investigator, female subjects of child bearing potential who do not agree to use a highly effective method of contraception.
- Any condition as determined by the investigator that would place a subject at an increased risk, or preclude subject's full compliance with the study procedures and visits.
- Female subjects who are known to be or found to be, pregnant or lactating.
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 |
|---|---|---|
| Epoetin Hospira ArmEpoetin Hospira Arm: Epoetin Hospira will be administered intravenously (IV) per the analogous version of the Fresenius Medical Care North America (FMCNA) cMAB 1 (inclusive of version 1.0, 1.1,...)erythropoietin stimulating agents (ESA) dosing algorithm for Epoetin Hospira for 24 weeks. Subjects will have Epoetin Hospira initiated using the same ESA dose level and frequency of administration for Epogen prior to randomization into the trial. Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics. | Biological | Epoetin Hospira |
| Standard of Care ArmStandard of care arm: No interventions will be performed in this arm for the clinical study; and subjects will receive ongoing standard of care, which includes Epogen administered IV per the FMCNA cMAB 5 (inclusive of versions 5.0, 5.1,....) ESA dosing algorithm and IV iron per the FMCNA protocol that is standard of care, at FMCNA clinics during the contemporaneous 24 week period. | Other | Standard of Care |
| IV IronSubjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics. | Drug | Epoetin Hospira, Standard of Care |
Primary outcome
Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)
Time frame: Week 17 up to Week 24
1 secondary outcome
Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment
Time frame: Baseline (8 Weeks prior to randomization), Week 17 up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- 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.
- Derived from this study: PubMed 30196301Thadhani R, Guilatco R, Hymes J, Maddux FW, Ahuja A. Switching from Epoetin Alfa (Epogen(R)) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis. Am J Nephrol. 2018;48(3):214-224. doi: 10.1159/000492621. Epub 2018 Sep 7.
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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.
Pfizer CT.gov Call Center study director
Pfizer
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin Hospira Arm and IV Iron in people with Chronic Kidney Disease (CKD), run by Pfizer at 45 sites in 2 countries.
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 7 inclusion and 14 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 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Puerto Rico. 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 13 Jun 2018). 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 Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL) (time frame: Week 17 up to 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 NCT02504294, 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 13 Jun 2018.