A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin

This study has been completed.
Sponsor:
Information provided by:
FibroGen
ClinicalTrials.gov Identifier:
NCT00456053
First received: April 2, 2007
Last updated: November 2, 2007
Last verified: November 2007

April 2, 2007
November 2, 2007
December 2005
Not Provided
Hemoglobin (Hb) response
Same as current
Complete list of historical versions of study NCT00456053 on ClinicalTrials.gov Archive Site
  • Attainment of Hb target range (11-13)
  • Duration of maintenance of Hb in target range (11-13)
  • Safety
Same as current
Not Provided
Not Provided
 
A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin
A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin
The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Renal Anemia
Drug: FG2216
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
July 2007
Not Provided

Inclusion Criteria:

  • Stage 3 or 4 chronic kidney disease
  • appropriate hemoglobin levels

Exclusion Criteria:

  • Neovascular age related macular degeneration requiring treatment
  • Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment
  • Any history of malignancy
  • Therapy with recombinant erythropoietin or red blood cell transfusion within 4 weeks
  • Renal Transplant
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00456053
FGCL-SM2216-019
No
Not Provided
Not Provided
Not Provided
FibroGen
Not Provided
Not Provided
FibroGen
November 2007

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