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

Last updated on March 14, 2019

Study Location
California Institute of Renal Research
Chula Vista, California, 91910 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Kidney Disease (CKD)
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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

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

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,

- 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

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


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