A Study of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not Receiving Dialysis
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease, Anemia |
Therapuetic Areas: | Hematology, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/3/2019 |
Start Date: | November 2012 |
End Date: | September 20, 2018 |
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
The purpose of this study is to determine whether FG-4592 is safe and effective in the
treatment of anemia in chronic kidney disease patients who are not on dialysis.
treatment of anemia in chronic kidney disease patients who are not on dialysis.
There is a screening period of up to 6 weeks, a variable treatment period for individual
subjects. In order to complete the treatment period simultaneously for all study subjects,
the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration
of up to 3 years after the last subject is randomized, and a post-treatment follow-up period
of 4 weeks. Subjects were randomized in a 2:1 ratio to receive either roxadustat (FG-4592) or
placebo in a double-blind manner.
subjects. In order to complete the treatment period simultaneously for all study subjects,
the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration
of up to 3 years after the last subject is randomized, and a post-treatment follow-up period
of 4 weeks. Subjects were randomized in a 2:1 ratio to receive either roxadustat (FG-4592) or
placebo in a double-blind manner.
Inclusion Criteria:
- Chronic kidney disease, Stage 3, 4, or 5, not receiving dialysis
- Anemia qualified by measurements of hemoglobin values during screening
- Additional blood work must be in a safe range for study entry
- Body weight 45 to 160 kg
- Willingness to use contraception if of child-bearing potential
Exclusion Criteria:
- Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to
study participation
- More than one dose of intravenous iron within 12 weeks prior to study participation
- Blood transfusion within 8 weeks prior to study participation
- Active infection
- Chronic liver disease
- Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
- Uncontrolled blood pressure within 2 weeks prior to study participation
- Renal cell carcinoma
- History of malignancy, including multiple myeloma or other myelodysplastic syndrome
- Chronic inflammatory disease that could impact red blood cell production
- Any prior organ transplant, or a scheduled organ transplantation
- Anticipated elective surgery that is expected to lead to significant blood loss, or
anticipated elective heart procedure
- Gastrointestinal bleeding
- Any prior treatment with FG-4592 or a HIF-PHI
- Recent use of an investigational drug or treatment, or participation in an
investigational study
We found this trial at
57
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials