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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:
ClinicalTrials.gov Identifier:
NCT00456053
First Posted: April 4, 2007
Last Update Posted: November 6, 2007
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:
FibroGen
  Purpose
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.

Condition Intervention Phase
Renal Anemia Drug: FG2216 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • Hemoglobin (Hb) response

Secondary Outcome Measures:
  • Attainment of Hb target range (11-13)
  • Duration of maintenance of Hb in target range (11-13)
  • Safety

Enrollment: 145
Study Start Date: December 2005
Study Completion Date: July 2007
  Eligibility

Information from the National Library of Medicine

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

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
  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): NCT00456053


  Show 27 Study Locations
Sponsors and Collaborators
FibroGen
  More Information

ClinicalTrials.gov Identifier: NCT00456053     History of Changes
Other Study ID Numbers: FGCL-SM2216-019
First Submitted: April 2, 2007
First Posted: April 4, 2007
Last Update Posted: November 6, 2007
Last Verified: November 2007

Keywords provided by FibroGen:
Renal Anemia
Renal Failure
Kidney Disease
Human EPO

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics