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 |
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.
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.
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
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