Open Label Extension Study for the Long-term Efficacy and Safety of FG-4592 in Dialysis and Non-dialysis Chronic Kidney Disease Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01630889|
Recruitment Status : Unknown
Verified April 2016 by FibroGen.
Recruitment status was: Enrolling by invitation
First Posted : June 28, 2012
Last Update Posted : April 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease End Stage Renal Disease Anemia||Drug: FG-4592||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||December 2018|
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.
Other Name: Roxadustat
- Efficacy and Safety of FG-4592 treating anemia in dialysis and non-dialysis chronic kidney disease patients [ Time Frame: Up to 5 years. ]
- Evaluation of the long-term efficacy and safety of FG-4592 in the maintenance of hemoglobin (Hb) in dialysis and non-dialysis patients in CKD.
- Weekly FG-34592 doses and frequency of dose adjustments
- Need for recue therapies, consisting of either blood transfusion, IV iron or erythropoietins
- Safety: Vital signs, laboratory values, AEs and SAEs
- Evaluate FG-4592 doses and dose adjustments. [ Time Frame: Up to 5 years. ]
FG-4592 weekly total doses over time.
Dose adjustment frequencies during study duration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630889
|United States, California|
|Riverside, California, United States, 92505|
|United States, Maryland|
|Greenbelt, Maryland, United States, 20770|
|United States, North Carolina|
|Mountain Kidney & HTN Associates, PA|
|Asheville, North Carolina, United States, 28801|
|United States, Texas|
|Arlington, Texas, United States, 76015|
|Consolidated Medical Plaza|
|Caguas, Puerto Rico, 00725|
|CAIMED School of Medicine|
|Ponce, Puerto Rico, 00716|
|San Juan, Puerto Rico, 00918|
|Study Director:||Lona Poole, MD||FibroGen|