Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01630889
First received: June 8, 2012
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Chronic Kidney Disease
End Stage Renal Disease
Anemia
Drug: FG-4592
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • Efficacy and Safety of FG-4592 treating anemia in dialysis and non-dialysis chronic kidney disease patients [ Time Frame: Up to 5 years. ] [ Designated as safety issue: Yes ]
    • 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


Secondary Outcome Measures:
  • Evaluate FG-4592 doses and dose adjustments. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]

    FG-4592 weekly total doses over time.

    Dose adjustment frequencies during study duration.



Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FG-4592
FG-4592 Investigational Drug
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630889

Locations
United States, California
APEX Research
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 Nephrology
Arlington, Texas, United States, 76015
Puerto Rico
Consolidated Medical Plaza
Caguas, Puerto Rico, 00725
CAIMED School of Medicine
Ponce, Puerto Rico, 00716
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
FibroGen
Investigators
Study Director: Lona Poole, MD FibroGen
  More Information

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01630889     History of Changes
Other Study ID Numbers: FGCL-4592-059 
Study First Received: June 8, 2012
Last Updated: April 14, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by FibroGen:
Kidney
ESRD
End Stage Renal Disease
Anemia
Oral anemia treatment
Hemoglobin levels
Hemodialysis
CKD
Chronic Kidney Disease
Peritoneal
HD
PD
Hb
Erythropoietin
Blood count

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on December 09, 2016