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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456053

  Show 27 Study Locations
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00456053     History of Changes
Other Study ID Numbers: FGCL-SM2216-019
Study First Received: April 2, 2007
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014