Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Completed
First Posted : June 28, 2012
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
FibroGen

Tracking Information
First Submitted Date  ICMJE June 8, 2012
First Posted Date  ICMJE June 28, 2012
Last Update Posted Date June 29, 2020
Actual Study Start Date  ICMJE May 2012
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • End Stage Renal Disease
  • Anemia
Intervention  ICMJE 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  ICMJE Experimental: FG-4592
FG-4592 Investigational Drug
Intervention: Drug: FG-4592
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2020)
15
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2012)
150
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01630889
Other Study ID Numbers  ICMJE FGCL-4592-059
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party FibroGen
Study Sponsor  ICMJE FibroGen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lona Poole, MD FibroGen
PRS Account FibroGen
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP