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

Kyntra Bio145 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

145

Conditions

Renal Anemia

Interventions

FG2216DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Research Site

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Hemoglobin (Hb) response

Secondary Outcomes

Attainment of Hb target range (11-13)

Duration of maintenance of Hb in target range (11-13)

Safety

Data from ClinicalTrials.gov

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