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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01414075
First received: August 9, 2011
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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
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:
  • Maximum change in hemoglobin from baseline [ Time Frame: Weeks 3-13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number (%) of subjects with a hemoglobin response [ Time Frame: Weeks 5, 9, 13, 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Median time to hemoglobin response [ Time Frame: Week 3-13 ] [ Designated as safety issue: No ]
  • Changes from baseline observations in clinical assessments and clinical laboratory values [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: No ]
  • Change from baseline in SF-36 and FACT-An scores [ Time Frame: Weeks 1, 9, 13 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: May 2013
Estimated 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01414075     History of Changes
Other Study ID Numbers: FGCL-4592-053
Study First Received: August 9, 2011
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration
Hong Kong: Department of Health
Singapore: Health Sciences Authority
Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on May 16, 2013