A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
- Conditions
- Chronic Kidney Disease (CKD)
- Interventions
- Registration Number
- NCT02504294
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 432
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epoetin Hospira IV Iron Epoetin Hospira Arm Standard of Care Standard of Care Arm Standard of care arm Standard of Care IV Iron Standard of care arm Epoetin Hospira Epoetin Hospira Arm Epoetin Hospira Arm
- Primary Outcome Measures
Name Time Method Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL) Week 17 up to Week 24
- Secondary Outcome Measures
Name Time Method Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment Baseline (8 Weeks prior to randomization), Week 17 up to Week 24
Trial Locations
- Locations (36)
Briggs Avenue Dialysis Center
🇺🇸Durham, North Carolina, United States
California Institute of Renal Research at Fresenius Medical Care Kearny Mesa
🇺🇸San Diego, California, United States
Nephrology Associates, PC
🇺🇸Nashville, Tennessee, United States
North Gulfport
🇺🇸Gulfport, Mississippi, United States
Frenova Renal Research
🇺🇸Nampa, Idaho, United States
Metrolina Nephrology Associates, PA
🇺🇸Charlotte, North Carolina, United States
Fresenius Medical Care North America - Liberty Dialysis
🇺🇸Nampa, Idaho, United States
Fresenius Medical Care Paradise Valley
🇺🇸San Diego, California, United States
Fresenius Medical Care, Biloxi Dialysis Unit
🇺🇸Biloxi, Mississippi, United States
Fresenius Medical Care-Oshtemo
🇺🇸Kalamazoo, Michigan, United States
Paragon Health PC DBA Nephrology Center
🇺🇸Kalamazoo, Michigan, United States
Fresenius Medical Care-Franklin
🇺🇸Franklin, Tennessee, United States
FMC Charlotte
🇺🇸Charlotte, North Carolina, United States
FMC Matthews
🇺🇸Matthews, North Carolina, United States
Fresenius Medical Care Carolina
🇵🇷Carolina, Puerto Rico
Gamma Medical Research Inc
🇺🇸McAllen, Texas, United States
Fresenius Medical Care San Juan
🇵🇷San Juan, Puerto Rico
Mission Bend Dialysis (FMC#3971)
🇺🇸Houston, Texas, United States
Rosenberg Dialysis (FMC#1197)
🇺🇸Rosenberg, Texas, United States
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
Fresenius Medical Care
🇵🇷Humacao, Puerto Rico
Genesis Clinical Research, LLC
🇺🇸Tampa, Florida, United States
Fresenius Medical Care-Kalamazoo East
🇺🇸Kalamazoo, Michigan, United States
South Mississippi Kidney Center
🇺🇸Gulfport, Mississippi, United States
Durham Nephrology Associates
🇺🇸Durham, North Carolina, United States
Delaware Valley Nephrology and Hypertension Associates, PC
🇺🇸Philadelphia, Pennsylvania, United States
Fresenius Medical Care- Lansdale Dialysis
🇺🇸Lansdale, Pennsylvania, United States
Knoxville Kidney Center, PLLC
🇺🇸Knoxville, Tennessee, United States
Southwest Houston Research, Ltd.
🇺🇸Houston, Texas, United States
Fresenius Medical Care - Austin North 4478
🇺🇸Austin, Texas, United States
Fresenius Medical Care Weslaco
🇺🇸Weslaco, Texas, United States
Fresenius Crossville Dialysis Unit
🇺🇸Crossville, Tennessee, United States
Fresenius Dialysis West
🇺🇸Knoxville, Tennessee, United States
Research Management Inc
🇺🇸Austin, Texas, United States