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

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: NCT01244763
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
FibroGen

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease Anemia Drug: FG-4592 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Drug Drug: FG-4592
Different dose levels and schedules




Primary Outcome Measures :
  1. 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 :
  1. Evaluate FG-4592 dose requirement to correct Hemoglobin levels in target patient population [ Time Frame: 16-24 weeks ]
  2. 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

  3. 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

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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244763


Locations
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United States, Alabama
Mobile, Alabama, United States
United States, Arkansas
Pine Bluff, Arkansas, United States
United States, California
Azusa, California, United States
Chula Vista, California, United States
Downey, California, United States
Northridge, California, United States
Paramount, California, United States
Riverside, California, United States
Whittier, California, United States
Yuba City, California, United States
United States, Florida
Ft Lauderdale, Florida, United States
Lauderdale Lakes, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
United States, Georgia
Augusta, Georgia, United States
United States, Idaho
Meridian, Idaho, United States
United States, Kansas
Wichita, Kansas, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maryland
Bethesda, Maryland, United States
United States, Michigan
Detroit, Michigan, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New Jersey
Mt. Laurel, New Jersey, United States
United States, New York
Mineola, New York, United States
New York, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Raleigh, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
United States, South Carolina
Orangeburg, South Carolina, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Ft Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
Puerto Rico
Caguas, Puerto Rico
Ponce, Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
FibroGen
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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01244763    
Other Study ID Numbers: FGCL-4592-041
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency