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Study of FG-4592 in Non-Dialysis Chronic Kidney Disease Patients With Anemia

This study has been completed.
Information provided by (Responsible Party):
FibroGen Identifier:
First received: November 16, 2010
Last updated: January 28, 2013
Last verified: January 2013
The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in non-dialysis chronic kidney disease patients.

Condition Intervention Phase
Chronic Kidney Disease Anemia Drug: FG-4592 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FibroGen:

Primary Outcome Measures:
  • Hemoglobin response to treatment using various FG-4592 dosing regimens [ Time Frame: week 16-24 ]
    Cumulative number (%) of subjects with hemoglobin ≥ 11 g/dL and increase from baseline ≥ 1 g/dL

Secondary Outcome Measures:
  • Evaluate FG-4592 dose requirement to correct Hemoglobin levels in target patient population [ Time Frame: 16-24 weeks ]
  • Estimate pharmacokinetic parameters of FG-4592 in subset of patients [ Time Frame: week 2 ]
    Plasma FG-4592 concentration before and after dosing for exploratory population pharmacokinetics (PK) analysis

  • Assess iron utilization parameters during anemia therapy [ Time Frame: 16-24 weeks ]
    Iron utilization parameters: transferrin, Total iron-binding capacity (TIBC), Transferrin saturation (TSAT), ferritin, serum iron at specified time points

  • Assess Quality of Life Measures [ Time Frame: Day 1, Week 9, Week 17, End of Treatment ]
    Quality of life questionnaire scores

Enrollment: 145
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug Drug: FG-4592
Different dose levels and schedules


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 to 75 years
  2. Chronic kidney disease, not receiving dialysis
  3. Body weight 45 to 140 kg

Exclusion Criteria:

  1. Any clinically significant infection or evidence of an underlying infection
  2. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
  3. History of chronic liver disease
  4. New York Heart Association Class III or IV congestive heart failure
  5. Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
  6. History of malignancy
  7. Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
  8. History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
  9. History of hemosiderosis, hemochromatosis or polycystic kidney disease
  10. Active hemolysis or diagnosis of hemolytic syndrome
  11. Uncontrolled or symptomatic secondary hyperparathyroidism
  12. Seizure disorder or receiving anti-epilepsy medication
  13. Known bone marrow fibrosis
  14. Any prior or scheduled organ transplant
  15. Prior treatment with FG-4592 or any hypoxia-inducible factor prolyl hydroxylase inhibitor
  16. History of alcohol or drug abuse
  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 identifier: NCT01244763

  Show 38 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: FibroGen Identifier: NCT01244763     History of Changes
Other Study ID Numbers: FGCL-4592-041
Study First Received: November 16, 2010
Last Updated: January 28, 2013

Keywords provided by FibroGen:
Chronic Kidney Disease
Oral anemia treatment
Hemoglobin levels
Blood count

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency processed this record on September 21, 2017