Open Label Extension Study for the Long-term Efficacy and Safety of FG-4592 in Dialysis and Non-dialysis Chronic Kidney Disease Patients



Status:Enrolling by invitation
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2012
End Date:December 2018

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Open-Label Extension Study to Evaluate the Efficacy and Safety of FG-4592 for the Long-Term Maintenance Treatment of Anemia in Dialysis and Non-Dialysis Patients With Chronic Kidney Disease

The purpose of this open-label extension study is to evaluate long-term efficacy and safety
of FG-4592 in maintaining hemoglobin in dialysis and non-dialysis CKD patients who have
completed the Treatment Period of an FG-4592 FibroGen-sponsored anemia study.

This is an open-label, long-term maintenance study of FG-4592 anemia therapy in dialysis and
non-dialysis Chronic Kidney Disease patients who have completed the Treatment Period of an
FG-4592 FibroGen-sponsored anemia Study. Subjects assigned to FG-4592 in the previous study
will continue to receive the same FG-4592 dose and dosing frequency, unless a dose
adjustment is required. An optional treatment group may allow subjects assigned to placebo
in the previous study to start active FG-4592 study treatment.

Inclusion Criteria:

1. Minimum age 18 years

2. Completed the Treatment Period of an ongoing FG-4592 FibroGen-sponsored anemia study
in the U.S.

Exclusion Criteria

1. Subjects assigned to epoetin alfa in a previous ongoing FG-4592 anemia study

2. Pregnant or breastfeeding females

3. Females of childbearing potential, unless using contraception as detailed in the
protocol; male subjects with sexual partners of childbearing potential who are not on
birth control unless the male subject agrees to use contraception

4. Subjects who received FG-4592 in a previous study that did not demonstrate adequate
hemoglobin response per the investigator's clinical judgment

5. Any medical condition that in the opinion of the investigator may pose a safety risk
to a subject in this study, or which may interfere with study participation
We found this trial at
5
sites
Asheville, North Carolina 28801
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Arlington, Texas
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Arlington, TX
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Caguas,
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Greenbelt, MD
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Riverside, California 92505
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Riverside, CA
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