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Study of FG-4592 to Correct Anemia in New Dialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414075
First Posted: August 11, 2011
Last Update Posted: April 22, 2014
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.
Information provided by (Responsible Party):
FibroGen
  Purpose
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.

Condition Intervention Phase
Dialysis 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:
  • Maximum change in hemoglobin from baseline [ Time Frame: Weeks 3-13 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: July 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug Drug: FG-4592
Tiered, weight-based dosing with or without oral or intravenous iron supplementation

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01414075


Locations
United States, California
Northridge, California, United States
Yuba City, California, United States
United States, Michigan
Detroit, Michigan, United States
Hong Kong
Hong Kong, Hong Kong
Russian Federation
Moscow, Russian Federation
St. Petersburg, Russian Federation
Singapore
Singapore, Singapore
Sponsors and Collaborators
FibroGen
  More Information

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01414075     History of Changes
Other Study ID Numbers: FGCL-4592-053
First Submitted: August 9, 2011
First Posted: August 11, 2011
Last Update Posted: April 22, 2014
Last Verified: April 2014

Keywords provided by FibroGen:
Kidney
ESRD
Renal
End-Stage Renal Disease
Anemia
Oral anemia treatment
Hemoglobin levels
Hemodialysis
Peritoneal
HD
PD
Hb
Erythropoietin
Blood count

Additional relevant MeSH terms:
Anemia
Hematologic Diseases