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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00456053
FGCL-SM2216-019
No
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