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A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis

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ClinicalTrials.gov Identifier: NCT02504294
Recruitment Status : Completed
First Posted : July 21, 2015
Results First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 20, 2015
First Posted Date  ICMJE July 21, 2015
Results First Submitted Date  ICMJE May 16, 2018
Results First Posted Date  ICMJE June 13, 2018
Last Update Posted Date June 13, 2018
Actual Study Start Date  ICMJE July 13, 2015
Actual Primary Completion Date July 2, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
For each group, the proportion of subjects who maintain a mean hemoglobin level between 9 to 11 g/dL, using analogous dosing algorithms (FMCNA cMAB corporate algorithm 5) for each erythropoietin stimulating agents (ESA) [ Time Frame: Over the final 8 weeks of the study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
For each group, the change from baseline in the mean ESA dose per patient per week, using analogous dosing algorithms (FMCNA cMAB corporate algorithm 5) for each ESA [ Time Frame: Over the final 8 weeks of the study ]
Baseline defined as the mean ESA dose per patient per week over the 8 week period prior to randomization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Biological: 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.
  • Other: 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.
  • Drug: IV Iron
    Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Study Arms  ICMJE
  • Epoetin Hospira
    Epoetin Hospira Arm
    Interventions:
    • Biological: Epoetin Hospira Arm
    • Drug: IV Iron
  • Standard of Care
    Standard of care arm
    Interventions:
    • Other: Standard of Care Arm
    • Drug: IV Iron
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
 (submitted: September 23, 2016)
432
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2015)
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:

  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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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