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

August 9, 2011
March 5, 2013
July 2011
May 2013   (final data collection date for primary outcome measure)
Maximum change in hemoglobin from baseline [ Time Frame: Weeks 3-13 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01414075 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of FG-4592 to Correct Anemia in New Dialysis Patients
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Hong Kong,   Russian Federation,   Singapore
 
NCT01414075
FGCL-4592-053
Yes
FibroGen
FibroGen
Not Provided
Not Provided
FibroGen
March 2013

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