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

• ClinicalTrials.gov Identifier: NCT01630889
• Recruitment Status: Completed
• First Posted: June 28, 2012
• Last Update Posted: June 29, 2020
• Sponsor: FibroGen
• Information provided by (Responsible Party): FibroGen

Tracking Information

• First Submitted Date: June 8, 2012
• First Posted Date: June 28, 2012
• Last Update Posted Date: June 29, 2020
• Actual Study Start Date: May 2012
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 14, 2016)

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

Original Primary Outcome Measures (submitted: June 27, 2012)

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. ]

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.

Current Secondary Outcome Measures (submitted: April 14, 2016)

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.

Original Secondary Outcome Measures (submitted: June 27, 2012)

Evaluate FG-4592 doses and dose adjustments. [ Time Frame: Up to 2 years. ]

FG-4592 weekly total doses over time. Dose adjustment frequencies during study duration.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Label Extension Study for the Long-term Efficacy and Safety of FG-4592 in Dialysis and Non-dialysis Chronic Kidney Disease Patients
• 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
• Brief Summary: 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.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Chronic Kidney Disease
• End Stage Renal Disease
• Anemia

Intervention

Drug: FG-4592

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

Study Arms

Experimental: FG-4592

FG-4592 Investigational Drug

Intervention: Drug: FG-4592

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 24, 2020): 15
• Original Estimated Enrollment (submitted: June 27, 2012): 150
• Actual Study Completion Date: December 2019
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT01630889
• Other Study ID Numbers: FGCL-4592-059
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: FibroGen
• Study Sponsor: FibroGen
• Collaborators: Not Provided

Investigators

• Study Director: Lona Poole, MD; FibroGen

• PRS Account: FibroGen
• Verification Date: June 2020