Vadanem gains clinical evidence in renal anemia

Presents latest clinical evidence…. experts discuss treatment strategies with HIF-PHIs

Post hoc and meta-analysis data reinforce the drug's clinical value

Treatment strategies for renal anemia in patients with chronic kidney disease (CKD) are expanding beyond conventional erythropoiesis-stimulating agents (ESAs) toward more individualized approaches based on patient characteristics.

In particular, growing attention is being paid to the role of hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) in patients with ESA hyporesponsiveness or disordered iron metabolism, prompting active discussion on how these agents can be incorporated into clinical practice based on accumulating real-world clinical evidence.

At the 46th Annual Meeting of the Korean society of Nephrology (KSN 2026) held by the Korean society of Nephrology in Seoul, a symposium highlighted the practical potential of Vadanem (vadadustat) based on the latest clinical evidence and real-world experience in the treatment of renal anemia.

Speakers from Japan, Korea, Canada, and Taiwan shared the latest evidence on HIF-PHIs, evolving treatment paradigms, and country-specific clinical experience. The presentations focused on the clinical value of Vadanem and its use in practice.

Renal anemia develops as CKD progresses, leading to a decrease in the production of endogenous erythropoietin (EPO) and is frequently accompanied by functional iron deficiency associated with inflammation. Consequently, some patients exhibit hyporesponsiveness, showing insufficient response to existing ESA therapy, which raises the need for new treatment strategies.

Professor Masaomi Nangaku, The University of Tokyo

Professor Masaomi Nangaku of The University of Tokyo presented results from a post hoc win statistics analysis of the INNO2VATE study, which enrolled patients receiving maintenance hemodialysis.

The professor introduced results of the win statistics analysis comparing Vadanem with darbepoetin alfa. It used a hierarchical approach that prioritized clinically meaningful outcomes such as death and hospitalization. Results showed that Vadanem reduced the risk of death or hospitalization compared with darbepoetin alfa in analyses covering both the overall study period and the treatment period.

Professor Nangaku said, “Vadanem demonstrated consistent non-inferiority to conventional ESA therapy with respect to major adverse cardiovascular events (MACE) regardless of patients' age, sex or geographic region.”

He also suggested that the therapy may be particularly useful in patients with ESA hyporesponsiveness, elevated C-reactive protein (CRP) levels indicating inflammation, or reduced glomerular filtration rate (GFR).

Prof. Sungjin Chung, Yeouido St. Mary's Hospital, who presented as a Korean expert, added that many dialysis patients in routine clinical practice still fail to achieve target hemoglobin (Hb) levels despite adequate ESA therapy or require repeated dose escalation in Korea.

"In these patients, treatment strategies should consider ESA hyporesponsiveness or resistance, creating a greater role and need for new therapeutic options.”

Professor Chung added, “A meta-analysis of 10 randomized controlled trials (RCTs) demonstrated that Vadanem achieved comparable hemoglobin correction and maintenance to darbepoetin alfa, while maintaining a similar safety profile.

Furthermore, based on its mechanism of regulating iron absorption, transport, and utilization through the HIF pathway, it is expected to improve iron utilization by reducing hepcidin. Also, its ability to induce physiological erythropoietic responses was presented as a clinical advantage.

During the panel discussion, experts also discussed the long-term safety of HIF-PHIs and their potential role in future treatment strategies.

The panel noted that concerns regarding malignancy and thromboembolic events reported with certain HIF-PHIs should not be generalized to the entire class. Instead, treatment decisions should consider the characteristics of individual agents and appropriate patient management.

The experts further observed that although the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines currently recommend ESA therapy as the preferred initial treatment, continued accumulation of clinical evidence and long-term safety data could establish HIF-PHIs as an important therapeutic option in the future.

They also suggested that HIF-PHIs are likely to expand treatment options by diversifying treatment strategies according to patient characteristics, rather than simply replacing ESA.

Tanabe Pharma Korea said, "KSN 2026 is an important venue where the latest findings and innovative treatment methods in the field of nephrology from around the world are shared. Based on a solid partnership with the Korean Society of Nephrology, we will spare no effort for medical advancement and the promotion of human health.”