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: June 27, 2012
Last verified: June 2012
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 150
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)
Groups/Cohorts Assigned Interventions
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.

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Chronic Kidney Disease on dialysis and non-dialysis.

Criteria

Inclusion Criteria:

  • Minimum age 18 years
  • Completed the Treatment Period of an ongoing FG-4592 FibroGen-sponsored anemia study

Exclusion Criteria:

  • Treatment with an ESA study medication in a previous FG-4592 FibroGen-sponsored anemia Study
  • Pregnant or breastfeeding females
  • Inadequate hemoglobin response, per investigator's clinical judgement, to treatment with FG-4592 in a previous FibroGen anemia study
  • Medical condition that, in the opinion of the investigator, poses a safety risk to a subject in this study, or 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
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
Puerto Rico
Caguas, Puerto Rico
Ponce, Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

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: June 27, 2012
Health Authority: United States: Food and Drug Administration

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
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 20, 2014