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

Phase 3

Completed

• Conditions: Chronic Kidney Disease (CKD)
• Interventions: Other: Standard of Care Arm; Biological: Epoetin Hospira Arm; Drug: IV Iron

• 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.

Study Timeline

• Study Start: 2015-07-13
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Primary Completion: 2016-07-02
• Study Completion: 2016-07-16
• Disposition First Submitted: 2017-09-07
• Disposition First Submitted QC: 2017-09-20
• Disposition First Posted: 2017-09-28
• Status Verified: 2018-05
• Results First Submitted: 2018-05-16
• Results First Submitted QC: 2018-05-16
• Last Update Submitted: 2018-05-16
• Results First Posted: 2018-06-13
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

Not provided

Exclusion Criteria

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)

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; 🇵🇷 Humacao, Puerto Rico

Genesis Clinical Research, LLC; 🇺🇸 Tampa, Florida, 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

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