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

Area of Science:

• Nephrology
• Cardiovascular Medicine
• Pharmacology

Background:

• Anemia is a common complication in patients with chronic kidney disease (CKD).
• Assessing new anemia therapies in CKD is crucial for patient management.
• The ASCEND-ND trial focuses on novel prolyl hydroxylase inhibitors.

Purpose of the Study:

• To define the efficacy and safety of daprodustat versus darbepoetin alfa.
• To evaluate daprodustat in patients with CKD Stages 3-5 not on dialysis.
• To compare treatment outcomes for anemia in non-dialysis CKD patients.

Main Methods:

• The ASCEND-ND trial randomized 3872 adult CKD patients.
• Participants received either daprodustat or darbepoetin alfa (1:1 ratio).
• Co-primary endpoints included mean Hb change and major adverse cardiovascular events.

Main Results:

• The study included diverse CKD patients (median age 67, 56% female).
• Baseline characteristics showed 53% ESA non-users, 57% with diabetes, 37% with CV disease history.
• Demographics were comparable to similar large non-dialysis anemia trials.

Conclusions:

• ASCEND-ND will establish daprodustat's efficacy and safety profile.
• The trial provides critical data for treating anemia in non-dialysis CKD patients.
• Results will inform therapeutic decisions comparing daprodustat and darbepoetin alfa.