Study of FG-4592 to Correct Anemia in New Dialysis 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. Identifier: NCT01414075
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : April 22, 2014
Information provided by (Responsible Party):

August 9, 2011
August 11, 2011
April 22, 2014
July 2011
May 2013   (Final data collection date for primary outcome measure)
Maximum change in hemoglobin from baseline [ Time Frame: Weeks 3-13 ]
Same as current
Complete list of historical versions of study NCT01414075 on Archive Site
  • Number (%) of subjects with a hemoglobin response [ Time Frame: Weeks 5, 9, 13, 16 ]
    Defined as an increase in hemoglobin by ≥ 1.0 g/dL from baseline.
  • Number (%) of subjects achieving hemoglobin 11.0 - 13.0 g/dL [ Time Frame: Weeks 5-13 ]
  • Median time to hemoglobin response [ Time Frame: Week 3-13 ]
  • Changes from baseline observations in clinical assessments and clinical laboratory values [ Time Frame: Weeks 1-16 ]
  • Number of subjects with adverse events [ Time Frame: Weeks 1-16 ]
  • Change from baseline in SF-36 and FACT-An scores [ Time Frame: Weeks 1, 9, 13 ]
Same as current
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Study of FG-4592 to Correct Anemia in New Dialysis Patients
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The purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in patients with end-stage renal disease who recently started dialysis.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Dialysis
  • Anemia
Drug: FG-4592
Tiered, weight-based dosing with or without oral or intravenous iron supplementation
Experimental: Experimental Drug
Intervention: Drug: FG-4592
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18 to 80 years
  2. Receiving hemodialysis or peritoneal dialysis for end- stage renal disease (ESRD) for 2 weeks to 4 months.
  3. Hemoglobin < 10 g/dL
  4. Body weight 40 to 140 kg

Exclusion Criteria:

  1. Previously received erythropoiesis-stimulating agents
  2. Received IV iron within 4 weeks prior to randomization
  3. Received red blood cell transfusion within 8 weeks prior to randomization
  4. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
  5. History of chronic liver disease
  6. Clinically significant infection
  7. New York Heart Association Class III or IV congestive heart failure
  8. History of cancer within the past 4 years
  9. Chronic inflammatory disease even if it is in remission
  10. History of other blood disorders
  11. Active hemolysis or diagnosis of hemolytic syndrome
  12. Known bone marrow fibrosis
  13. Uncontrolled or symptomatic secondary hyperparathyroidism
  14. History of alcohol or drug abuse
  15. History of allergy or sensitivity to oral or intravenous iron
  16. Heart attack, deep vein thrombosis, or pulmonary embolism in the past 3 months
  17. Seizure disorder or receiving anti-epilepsy medication
  18. Pregnant or breast-feeding females
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   Russian Federation,   Singapore,   United States
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April 2014

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