Real-World Safety and Effectiveness of Vadadustat in Patients with Chronic Kidney Disease-Related Anemia: Interim Analysis of Postmarketing Surveillance in Japan.

ABSTRACT:

Introduction

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat chronic kidney disease (CKD)-related anemia. This interim analysis presents findings from postmarketing surveillance (PMS) conducted in Japan, assessing the safety and effectiveness of vadadustat in real-world clinical practice.

Methods

This ongoing 2-year observational, multicenter, prospective surveillance collected data from November 2020 to June 2024 to assess adverse drug reactions (ADRs) and hemoglobin (Hb) levels in patients with CKD-related anemia. ADRs of special interest included malignant tumors, thromboembolism, hepatic impairment, hypertension, cardiovascular events excluding thromboembolism, retinal hemorrhage-related ADRs, and the progression of autosomal dom

SUBMITTER: Nangaku M 

PROVIDER: S-EPMC12394292 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature