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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

Primary Purpose

Renal Anemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FG2216
Sponsored by
FibroGen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Anemia focused on measuring Renal Anemia, Renal Failure, Kidney Disease, Human EPO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
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  • 3 Research Sites
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Outcomes

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

Full Information

First Posted
April 2, 2007
Last Updated
November 2, 2007
Sponsor
FibroGen
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1. Study Identification

Unique Protocol Identification Number
NCT00456053
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
FibroGen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Anemia
Keywords
Renal Anemia, Renal Failure, Kidney Disease, Human EPO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FG2216
Primary Outcome Measure Information:
Title
Hemoglobin (Hb) response
Secondary Outcome Measure Information:
Title
Attainment of Hb target range (11-13)
Title
Duration of maintenance of Hb in target range (11-13)
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
3 Research Sites
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Oakland
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Santa Clara
State/Province
California
Country
United States
Facility Name
Research Site
City
Lauderdale Lakes
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
South Holland
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Pontiac
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Flushing
State/Province
New York
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Orangeburg
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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