Clinical trial NCT02504294: A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease (CKD)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2015-07-21
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)
timeFrame: Week 17 up to Week 24
Secondary outcomes:
measure: Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment
timeFrame: Baseline (8 Weeks prior to randomization), Week 17 up to Week 24
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: California Institute of Renal Research
state: California
city: Poway
country: United States
facility: California Institute of Renal Research at Fresenius Medical Care
state: California
city: Rancho Bernardo
country: United States
facility: Fresenius Medical Care Rancho
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research at Fresenius Medical Care Kearny Mesa
state: California
city: San Diego
country: United States
facility: Fresenius Medical Care Paradise Valley
state: California
city: Tampa
country: United States
facility: Fresenius Medical Care
state: Florida
city: Tampa
country: United States
facility: Fresenius Medical Care
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
city: Boise
country: United States
facility: Frenova Renal Research
state: Idaho
city: Boise
country: United States
facility: Fresenius Medical Care North America - Liberty Dialysis
state: Idaho
city: Caldwell
country: United States
facility: Frenova Renal Research
state: Idaho
city: Caldwell
country: United States
facility: Fresenius Medical Care North America - Liberty Dialysis
state: Idaho
city: Meridian
country: United States
facility: Frenova Renal Research
state: Idaho
city: Meridian
country: United States
facility: Fresenius Medical Care North America - Liberty Dialysis
state: Idaho
city: Nampa
country: United States
facility: Frenova Renal Research
state: Idaho
city: Nampa
country: United States
facility: Fresenius Medical Care North America - Liberty Dialysis
state: Idaho
city: Kalamazoo
country: United States
facility: Fresenius Medical Care-Kalamazoo East
state: Michigan
city: Kalamazoo
country: United States
facility: Paragon Health PC DBA Nephrology Center
state: Michigan
city: Kalamazoo
country: United States
facility: Fresenius Medical Care-Oshtemo
state: Michigan
city: Biloxi
country: United States
facility: Fresenius Medical Care, Biloxi Dialysis Unit
state: Mississippi
city: Gulfport
country: United States
facility: North Gulfport
state: Mississippi
city: Gulfport
country: United States
facility: South Mississippi Kidney Center
state: Mississippi
city: Charlotte
country: United States
facility: FMC Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates, PA
state: North Carolina
city: Durham
country: United States
facility: Briggs Avenue Dialysis Center
state: North Carolina
city: Durham
country: United States
facility: Durham Nephrology Associates
state: North Carolina
city: Matthews
country: United States
facility: FMC Matthews
state: North Carolina
city: Lansdale
country: United States
facility: Fresenius Medical Care- Lansdale Dialysis
state: Pennsylvania
city: Philadelphia
country: United States
facility: Delaware Valley Nephrology and Hypertension Associates, PC
state: Pennsylvania
city: Warwick
country: United States
facility: Fresenius Medical Care
state: Rhode Island
city: Crossville
country: United States
facility: Fresenius Crossville Dialysis Unit
state: Tennessee
city: Franklin
country: United States
facility: Fresenius Medical Care-Franklin
state: Tennessee
city: Knoxville
country: United States
facility: Knoxville Kidney Center, PLLC
state: Tennessee
city: Knoxville
country: United States
facility: Fresenius Dialysis West
state: Tennessee
city: Nashville
country: United States
facility: Nephrology Associates, PC
state: Tennessee
city: Austin
country: United States
facility: Fresenius Medical Care - Austin North 4478
state: Texas
city: Austin
country: United States
facility: Research Management Inc
state: Texas
city: Houston
country: United States
facility: Mission Bend Dialysis (FMC#3971)
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research, Ltd.
state: Texas
city: McAllen
country: United States
facility: Gamma Medical Research Inc
state: Texas
city: Rosenberg
country: United States
facility: Rosenberg Dialysis (FMC#1197)
state: Texas
city: Weslaco
country: United States
facility: Fresenius Medical Care Weslaco
state: Texas
city: Carolina
country: Puerto Rico
facility: Fresenius Medical Care Carolina
city: Humacao
country: Puerto Rico
facility: Fresenius Medical Care
city: San Juan
country: Puerto Rico
facility: Fresenius Medical Care San Juan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.