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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00456053

Enrollment

145

Registered

2007-04-04

Start date

2005-12-31

Completion date

2007-07-31

Last updated

2007-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Anemia

Keywords

Renal Anemia, Renal Failure, Kidney Disease, Human EPO

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.

Interventions

DRUGFG2216

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Hemoglobin (Hb) response	—

Secondary

Measure	Time frame
Attainment of Hb target range (11-13)	—
Duration of maintenance of Hb in target range (11-13)	—
Safety	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026