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CompletedNCT01599507

Study of FG-4592 in Subjects With Chronic Kidney Disease in China

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose Ranging Safety and Efficacy Study of FG 4592 in Non-dialysis Chronic Kidney Disease (CKD) Subjects With Anemia

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
91 (actual)
Sponsor
Kyntra Bio · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in non-dialysis chronic kidney disease patients.

Detailed description

Dose ranging study with two consecutive dose escalation cohorts. The study objective is to demonstrate that FG-4592 is effective in the correction of anemia in chronic kidney disease patients.

Conditions

Interventions

TypeNameDescription
DRUGFG-4592TIW dosing, capsule
DRUGPlaceboTIW dosing, capsule

Timeline

Start date
2011-12-01
Primary completion
2013-01-01
Completion
2013-01-01
First posted
2012-05-16
Last updated
2014-03-03

Locations

13 sites across 1 country: China

Source: ClinicalTrials.gov record NCT01599507. Inclusion in this directory is not an endorsement.

Study of FG-4592 in Subjects With Chronic Kidney Disease in China (NCT01599507) · Clinical Trials Directory