A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
NCT02504294
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Subjects eligible to be entered into the study will meet all of the following criteria:
1. Adult female or male subjects; age ≥ 18 years.
2. End stage renal disease subjects treated in-center with the modality of hemodialysis for ≥ 120 days.
3. Diagnosed with anemia.
4. 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.
5. Currently using the IV Epogen version of the ESA dosing algorithm cMAB 5 (inclusive of versions 5.0, 5.1, …) for anemia management.
6. Receiving hemodialysis at a clinic using the FMCNA dosing algorithm for IV iron that is the FMCNA standard of care treatment for iron replacement.
Subjects that meet any of the following criteria will be ineligible to be entered into the
interventional cohort:
1. Subjects unable to provide a signed and dated informed consent for this clinical
research study.
2. As determined by the Investigator, female subjects of child bearing potential who do
not agree to use a highly effective method of contraception.
3. 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.
4. Female subjects who are known to be or found to be, pregnant or lactating.
5. 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.
6. Treatment with any investigational drug within 30 days prior to randomization and
throughout this clinical trial.
7. 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.
8. 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.
9. Subjects currently receiving a long acting ESA, or who have received a long acting ESA
in the 16 weeks prior to study randomization
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Descriptive Information | ||||
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Brief Title ICMJE | A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other | |||
Condition ICMJE | Chronic Kidney Disease (CKD) | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Thadhani R, Guilatco R, Hymes J, Maddux FW, Ahuja A. Switching from Epoetin Alfa (Epogen®) 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 432 | |||
Original Estimated Enrollment ICMJE | 900 | |||
Actual Study Completion Date ICMJE | July 16, 2016 | |||
Actual Primary Completion Date | July 2, 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria Subjects eligible to be entered into the study will meet all of the following criteria:
Exclusion Criteria Subjects that meet any of the following criteria will be ineligible to be entered into the interventional cohort:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02504294 | |||
Other Study ID Numbers ICMJE | ZIN-EPO-1503 C3461008 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Hospira, now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | May 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |