Vascular Access Thrombosis Events in Patients With Dialysis-Dependent CKD Treated With Vadadustat or Darbepoetin Alfa: The INNO₂VATE Trial Program.

ABSTRACT:

Rationale & objective

In the global phase 3 INNO₂VATE program of patients with dialysis-dependent chronic kidney disease (DD-CKD) and CKD-related anemia (2 trials: patients new to [NCT02865850] and established on maintenance dialysis [NCT02892149]), vadadustat was noninferior to the erythropoiesis-stimulating agent darbepoetin alfa for cardiovascular safety and hemoglobin efficacy. Here, we investigated between-group differences in positively adjudicated vascular access thrombosis (VAT) events.

Study design

Phase 3, global, open-label, randomized, active-controlled clinical trials.

Setting & participants

A total of 3,902 patients who initiated dialysis within the past 16 weeks (incident DD-CKD trial; N = 365) or who had been treated with dialysis for >12 we

SUBMITTER: Winkelmayer WC 

PROVIDER: S-EPMC12051538 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature