A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
NCT ID: NCT02504294
Last Updated: 2018-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
432 participants
INTERVENTIONAL
2015-07-13
2016-07-16
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Epoetin Hospira
Epoetin Hospira Arm
Epoetin Hospira Arm
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.
IV Iron
Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Standard of Care
Standard of care arm
Standard of Care Arm
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 Iron
Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Interventions
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Epoetin Hospira Arm
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 Arm
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 Iron
Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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California Institute of Renal Research
Chula Vista, California, United States
California Institute of Renal Research at Fresenius Medical Care
Poway, California, United States
Fresenius Medical Care Rancho
Rancho Bernardo, California, United States
California Institute of Renal Research at Fresenius Medical Care Kearny Mesa
San Diego, California, United States
Fresenius Medical Care Paradise Valley
San Diego, California, United States
Fresenius Medical Care
Tampa, Florida, United States
Fresenius Medical Care
Tampa, Florida, United States
Genesis Clinical Research, LLC
Tampa, Florida, United States
Frenova Renal Research
Boise, Idaho, United States
Fresenius Medical Care North America - Liberty Dialysis
Boise, Idaho, United States
Frenova Renal Research
Caldwell, Idaho, United States
Fresenius Medical Care North America - Liberty Dialysis
Caldwell, Idaho, United States
Frenova Renal Research
Meridian, Idaho, United States
Fresenius Medical Care North America - Liberty Dialysis
Meridian, Idaho, United States
Frenova Renal Research
Nampa, Idaho, United States
Fresenius Medical Care North America - Liberty Dialysis
Nampa, Idaho, United States
Fresenius Medical Care-Kalamazoo East
Kalamazoo, Michigan, United States
Paragon Health PC DBA Nephrology Center
Kalamazoo, Michigan, United States
Fresenius Medical Care-Oshtemo
Kalamazoo, Michigan, United States
Fresenius Medical Care, Biloxi Dialysis Unit
Biloxi, Mississippi, United States
North Gulfport
Gulfport, Mississippi, United States
South Mississippi Kidney Center
Gulfport, Mississippi, United States
FMC Charlotte
Charlotte, North Carolina, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
Briggs Avenue Dialysis Center
Durham, North Carolina, United States
Durham Nephrology Associates
Durham, North Carolina, United States
FMC Matthews
Matthews, North Carolina, United States
Fresenius Medical Care- Lansdale Dialysis
Lansdale, Pennsylvania, United States
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, United States
Fresenius Medical Care
Warwick, Rhode Island, United States
Fresenius Crossville Dialysis Unit
Crossville, Tennessee, United States
Fresenius Medical Care-Franklin
Franklin, Tennessee, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States
Fresenius Dialysis West
Knoxville, Tennessee, United States
Nephrology Associates, PC
Nashville, Tennessee, United States
Fresenius Medical Care - Austin North 4478
Austin, Texas, United States
Research Management Inc
Austin, Texas, United States
Mission Bend Dialysis (FMC#3971)
Houston, Texas, United States
Southwest Houston Research, Ltd.
Houston, Texas, United States
Gamma Medical Research Inc
McAllen, Texas, United States
Rosenberg Dialysis (FMC#1197)
Rosenberg, Texas, United States
Fresenius Medical Care Weslaco
Weslaco, Texas, United States
Fresenius Medical Care Carolina
Carolina, , Puerto Rico
Fresenius Medical Care
Humacao, , Puerto Rico
Fresenius Medical Care San Juan
San Juan, , Puerto Rico
Countries
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References
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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.
Thadhani 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.
Other Identifiers
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C3461008
Identifier Type: OTHER
Identifier Source: secondary_id
ZIN-EPO-1503
Identifier Type: -
Identifier Source: org_study_id
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