Clinical trial NCT00456053: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Anemia
Keywords: Renal Anemia
Renal Failure
Kidney Disease
Human EPO
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2007-04-04
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hemoglobin (Hb) response
Secondary outcomes:
measure: Attainment of Hb target range (11-13)
measure: Duration of maintenance of Hb in target range (11-13)
measure: Safety
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Los Angeles
country: United States
facility: 3 Research Sites
state: California
city: Oakland
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Clara
country: United States
facility: Research Site
state: California
city: Lauderdale Lakes
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: South Holland
country: United States
facility: Research Site
state: Illinois
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Springfield
country: United States
facility: Research Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Research Site
state: Michigan
city: Pontiac
country: United States
facility: Research Site
state: Michigan
city: Flushing
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Orangeburg
country: United States
facility: Research Site
state: South Carolina
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Fairfax
country: United States
facility: Research Site
state: Virginia
Study officials:
References: