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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01244763
First received: November 16, 2010
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Estimate pharmacokinetic parameters of FG-4592 in subset of patients [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244763

  Show 38 Study Locations
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01244763     History of Changes
Other Study ID Numbers: FGCL-4592-041
Study First Received: November 16, 2010
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by FibroGen:
Kidney
Chronic Kidney Disease
CKD
Renal
Anemia
Oral anemia treatment
Hemoglobin levels
 Erythropoietin
Blood count
Predialysis
Pre-dialysis
Hb
Non-dialysis

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 May 19, 2013