Open Label Extension Study for the Long-term Efficacy and Safety of FG-4592 in Dialysis and Non-dialysis Chronic Kidney Disease Patients
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.
Chronic Kidney Disease
End Stage Renal Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
- Evaluation of the long-term efficacy and safety of FG-4592 in the maintenance of hemoglobin (Hb) in dialysis and nondialysis patients in CKD. [ Time Frame: Up to 2 years. ] [ Designated as safety issue: Yes ]
Efficacy: Mean monthly Hb values over time, number (%) of subjects mataining monthly mean Hb at >/= 10 g/dL, number of (%) of subjects maintaining Hb between 10-13 g/dL for at least 60% of the assessments.
Safety: Vital signs, laboratory values, AEs and SAEs.
- Evaluate FG-4592 doses and dose adjustments. [ Time Frame: Up to 2 years. ] [ Designated as safety issue: No ]
FG-4592 weekly total doses over time.
Dose adjustment frequencies during study duration.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
FG-4592 Investigational Drug
Subjects previously randomized to FG-4592 will receive study medication on the same dosing frequency assigned at the last dose of the previous FibroGen 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.
|United States, California|
|Riverside, California, United States|
|Yuba City, California, United States|
|United States, Florida|
|Miami, Florida, United States|
|United States, Maryland|
|Bethesda, Maryland, United States|
|United States, North Carolina|
|Asheville, North Carolina, United States|
|Caguas, Puerto Rico|
|Ponce, Puerto Rico|
|San Juan, Puerto Rico|