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

Sponsor

FibroGen (Industry)

Overall Status

Completed

CT.gov ID

NCT00456053

Collaborator

(none)

145

Enrollment

Locations

Duration (Months)

5.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Anemia	Drug: FG2216	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

145 participants

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

Study Start Date :

Dec 1, 2005

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Tucson	Arizona	United States
2	Research Site	Little Rock	Arkansas	United States
3	3 Research Sites	Los Angeles	California	United States
4	Research Site	Oakland	California	United States
5	Research Site	San Diego	California	United States
6	Research Site	Santa Clara	California	United States
7	Research Site	Lauderdale Lakes	Florida	United States
8	Research Site	Miami	Florida	United States
9	Research Site	Pembroke Pines	Florida	United States
10	Research Site	Atlanta	Georgia	United States
11	Research Site	South Holland	Illinois	United States
12	Research Site	Shreveport	Louisiana	United States
13	Research Site	Springfield	Massachusetts	United States
14	Research Site	Kalamazoo	Michigan	United States
15	Research Site	Pontiac	Michigan	United States
16	Research Site	Flushing	New York	United States
17	Research Site	Cincinnati	Ohio	United States
18	Research Site	Columbus	Ohio	United States
19	Research Site	Portland	Oregon	United States
20	Research Site	Allentown	Pennsylvania	United States
21	Research Site	Hershey	Pennsylvania	United States
22	Research Site	Pittsburgh	Pennsylvania	United States
23	Research Site	Orangeburg	South Carolina	United States
24	Research Site	Houston	Texas	United States
25	Research Site	San Antonio	Texas	United States
26	Research Site	Chesapeake	Virginia	United States
27	Research Site	Fairfax	Virginia	United States