Two Phase 3 Studies on Ophthalmologic Effects of Roxadustat Versus Darbepoetin.

ABSTRACT:

Introduction

Roxadustat is an orally administered hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor that represents a novel therapeutic option for patients with anemia of chronic kidney disease (CKD).

Methods

Conducted in Japan, CL-0307 (NCT02952092) and CL-310 (NCT02988973) were phase 3, darbepoetin alfa (DA)-controlled studies conducted in dialysis-dependent (DD) and non-DD (NDD) patients with CKD, respectively, where patients were randomized to receive roxadustat or DA. Ophthalmic imaging and assessments of visual acuity were performed up to week 24 or at study discontinuation. Ophthalmic imaging was centrally evaluated by independent readers masked to the study treatment.

Results

In CL-0307, 302 patients (roxadustat, n = 150; DA, n = 152) r

SUBMITTER: Sepah YJ 

PROVIDER: S-EPMC9039484 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature