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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02504294
Other study ID # ZIN-EPO-1503
Secondary ID C3461008
Status Completed
Phase Phase 3
First received
Last updated
Start date July 13, 2015
Est. completion date July 16, 2016

Study information

Verified date May 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.


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 information / eligibility

Status Completed
Enrollment 432
Est. completion date July 16, 2016
Est. primary completion date July 2, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Puerto Rico Fresenius Medical Care Carolina Carolina
Puerto Rico Fresenius Medical Care Humacao
Puerto Rico Fresenius Medical Care San Juan San Juan
United States Fresenius Medical Care - Austin North 4478 Austin Texas
United States Research Management Inc Austin Texas
United States Fresenius Medical Care, Biloxi Dialysis Unit Biloxi Mississippi
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 FMC Charlotte Charlotte North Carolina
United States Metrolina Nephrology Associates, PA Charlotte North Carolina
United States California Institute of Renal Research Chula Vista California
United States Fresenius Crossville Dialysis Unit Crossville Tennessee
United States Briggs Avenue Dialysis Center Durham North Carolina
United States Durham Nephrology Associates Durham North Carolina
United States Fresenius Medical Care-Franklin Franklin Tennessee
United States North Gulfport Gulfport Mississippi
United States South Mississippi Kidney Center Gulfport Mississippi
United States Mission Bend Dialysis (FMC#3971) Houston Texas
United States Southwest Houston Research, Ltd. Houston Texas
United States Fresenius Medical Care-Kalamazoo East Kalamazoo Michigan
United States Fresenius Medical Care-Oshtemo Kalamazoo Michigan
United States Paragon Health PC DBA Nephrology Center Kalamazoo Michigan
United States Fresenius Dialysis West Knoxville Tennessee
United States Knoxville Kidney Center, PLLC Knoxville Tennessee
United States Fresenius Medical Care- Lansdale Dialysis Lansdale Pennsylvania
United States FMC Matthews Matthews North Carolina
United States Gamma Medical Research Inc McAllen Texas
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 Nephrology Associates, PC Nashville Tennessee
United States Delaware Valley Nephrology and Hypertension Associates, PC Philadelphia Pennsylvania
United States California Institute of Renal Research at Fresenius Medical Care Poway California
United States Fresenius Medical Care Rancho Rancho Bernardo California
United States Rosenberg Dialysis (FMC#1197) Rosenberg Texas
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 Fresenius Medical Care Warwick Rhode Island
United States Fresenius Medical Care Weslaco Weslaco Texas

Sponsors (2)

Lead Sponsor Collaborator
Pfizer Hospira, now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL) Week 17 up to Week 24
Secondary 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
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