The ASCEND-ND trial: study design and participant characteristics.

ABSTRACT:

Background

Anaemia is common in chronic kidney disease (CKD) and assessment of the risks and benefits of new therapies is important.

Methods

The Anaemia Study in CKD: Erythropoiesis via a Novel prolyl hydroxylase inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) trial includes adult patients with CKD Stages 3-5, not using erythropoiesis-stimulating agents (ESAs) with screening haemoglobin (Hb) 8-10 g/dL or receiving ESAs with screening Hb of 8-12 g/dL. Participants were randomized to daprodustat or darbepoetin alfa (1:1) in an open-label trial (steering committee- and sponsor-blinded), with blinded endpoint assessment. The co-primary endpoints are mean change in Hb between baseline and evaluation period (average over Weeks 28-52) and time to first adjudicated major adverse card

SUBMITTER: Perkovic V 

PROVIDER: S-EPMC9585467 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature